Northside Hospital Gwinnett

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 47718 Based on the review of medical records, facility’s policies/procedures, and staff interviews, it was determined that the nursing staff failed to provide quality care/treatment for two patients (P) (P#1 and P#3) of three patients (P#1, P#2, and P#3) reviewed by failing to turn P#1 and P#3 every two hours as per the facility’s protocol. Findings included: 1. A review of P#1’s medical record revealed that P#1 was admitted to the facility on 1/25/25 with the diagnosis of Seizures (uncontrolled jerking, loss of consciousness, blank stares, or other symptoms caused by abnormal electrical activity in the brain). A review of the History and Physical (H&P) on 1/26/25 at 4:19 a.m. revealed that P#1 presented to the ED with stroke-like symptoms, severely altered mentation, and left-sided facial droop. Documentation revealed that P#1 had a seizure in the ED, now postictal (recovery period that begins after a seizure ends and lasts until the patient returns to their normal state). Keppra (a medication used to treat certain types of seizures in people with epilepsy) was ordered, and to follow up with Neurology (a medical specialty that studies and treats disorders of the nervous system). A review of the physician orders revealed an order for a moisture barrier cream on 1/26/25 at 9:46 p.m. for routine, Hydraguard (a water-resistant cream that moisturizes and nourishes the skin), every eight hours scheduled, and with morning care and after each episode of incontinence. Continued review of the physician orders revealed an order for Skin Integrity Impairment Prevention on 1/26/25 at 9:46 p.m. for routine, as directed, and PRN (as required). A review of the Wound Care Progress Note on 2/3/25 at 1:48 p.m. revealed that a consultation was placed to evaluate a wound/skin tear on P#1’s sacrum. Documentation revealed a defined area of dark discoloration along with some partial-thickness skin loss over the coccyx (bottom) suggestive of DTI (Deep Tissue Injury - a discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear) pressure injury. Recommendation revealed offloading the sacral area/buttocks with side-to-side tilts and Venelex (an ointment used in the management of dermal ulcers, including pressure ulcers) with silicone foam dressing to protect the skin from friction injury. P#1’s Braden score (a measurement of a patient’s risk of developing pressure ulcers) was 15. During the electronic medical record review, documentation revealed that on admission to the facility’s PCU (Progressive Care Unit), P#1’s skin assessment was documented as normal, warm, and intact. Documentation failed to reveal that P#1 had any wounds/ulcers present on admission. A continued review of the electronic medical record review at the facility revealed that P#1 was not turned every two hours as per protocol when she (P#1) was in the PCU unit, and turning was missed on the following days and times: 1/26/25 - At 8:00 p.m. and 10:00 p.m. From 1/27/25 to 1/29/25 - At 6:00 a.m. 1/30/25 - At 2:00 a.m. 1/31/25 - At 6:00 a.m. 2/2/25 - At 6:00 a.m., 12:00 p.m., and 4:00 p.m. Documentation revealed that P#1 was transferred to another unit in the same facility (6C - Medical-Surgical Unit) on 2/2/25 at 5:36 p.m. A Continued review of the electronic medical record revealed that during P#1’s skin assessment on admission to the 6C unit, a localized skin abnormality was documented to have been observed on 2/2/25 at 6:16 p.m., a skin tear was documented on 2/2/25 at 6:22 p.m., and a silicone foam border dressing was applied. Documentation also revealed that a wound care consultation was documented on 2/3/25 at 1:48 p.m. 2. P#3 was admitted to the facility via the Emergency Department (ED) on 8/19/24 with a diagnosis of Advance Care Planning (the process of preparing for and discussing future medical care decisions in case someone becomes unable to communicate wishes) and Anemia (a condition in which the blood does not have enough healthy red blood cells and hemoglobin). Documentation of the physical examination on 8/19/24 at 4:32 a.m. under the Emergency Documentation revealed that P#3’s skin examination was normal, warm, dry, and normal in color. A review of the History and Physical (H&P) on 8/19/24 at 10:03 a.m. revealed that P#3’s skin was warm, dry, and intact without rash. Documentation also revealed a left lower extremity skin tear, and wound care was consulted on 8/19/24. Further review of P#3’s electronic medical record revealed documentation on 8/19/24 at 7:08 p.m. that P#3 had a history of stage 4 decubitus (most severe form of skin damage caused by prolonged pressure on the body) from a previous admission and was admitted with a dressing on the left lower leg. A continued electronic medical record review revealed that a wound consultation was received for a left lower extremity skin tear with a history of stage 4 decubitus on 8/19/24. Documentation also revealed that P#3 was alert, resting in bed with nursing in attendance, and P#3 stated that the wound on her left leg was caused by the immobilizer she had to wear for support for her knee and hip for several years. P#3’s Braden score was 14. Documentation of the wound care notes revealed that P#3 had scarring from a previously healed pressure injury, scantly erythematous (redness of the skin, either in a limited area or all over), and blanches (white or pale). Recommendation revealed turning and repositioning was required, protective silicone foam dressing for protection of shear and moisture; Nursing to continue pressure injury prevention. The electronic medical record review also revealed that P#3 was not turned and repositioned every two hours as per protocol. Documentation revealed that turning/repositioning were missed at the following dates and times: 8/31/24 - P#3 was last turned at 7:00 a.m., and documentation failed to reveal another repositioning until 3:30 p.m. 9/1/24 - Turning/Repositioning was only documented at 8:32 a.m., 5:11 p.m., and 8:00 p.m. 9/2/24 - turned at midnight, and documentation failed to reveal another turning/repositioning until 4:00 a.m., 8:00 a.m., and then last at 4:59 p.m., and then not until 8:00 p.m. 9/3/24 - turned at midnight, and documentation failed to reveal another turning/repositioning until 7:00 a.m. 9/4/24- Documentation revealed that P#3 was last turned at 4:00 a.m. and not turned again until 3:00 p.m. and not until 7:00 p.m. 9/5/24 - Documentation revealed that P#3 was last turned at midnight and not until 7:33 a.m. and 11:31 a.m. 9/7/24 - last turned at 10:00 a.m. and not until 2:00 p.m. -9/8/24 - Documentation only revealed a turning/repositioning at 6:00 a.m., and not until 8:00 a.m. the next day (9/9/24). 9/9/24 - turning missed at 6:00 p.m. 9/10/24 - last turned at 5:00 p.m. and not until 9:00 p.m. Documentation also revealed P#3 refused turning/repositioning at 1:00 p.m. A continued review of P#3’s electronic medical record revealed documentation of a skin abnormality type on the Right middle sacrum on 9/5/24 at 4:11 p.m., documented as ‘purple.’ A review of the facility’s policy titled “Patient Rights and Responsibilities - SYSTEM,” Policy #11763, last revised 5/3/2023, revealed that individuals would be afforded impartial access to treatment or accommodations that were available and medically indicated, regardless of race, creed, color, sex, national origin, disability, age or source of payment for care. Patients had the right to expect reasonable safety as far as the facility’s practices and environment were concerned. The facility, to the best of its ability, will strive to protect patients from all forms of abuse or harassment. The facility had a process in place for the investigation of allegations or observations of suspected cases of abuse, neglect, or exploitation. Patients should be informed of the Hospital rules and regulations applicable to their conduct as patients. Patients are entitled to information about the Hospital’s mechanism for the initiation, review, and resolution of patient complaints without being subject to coercion, discrimination, reprisal, or unreasonable interruption of care. A review of the facility’s policy titled “Skin Integrity Protection and Wound Management - SYSTEM” Policy #29228, last revised 6/30/23, revealed that nursing staff to assess all patients on admission for individual risk for skin breakdown using the Braden Scale - Skin Integrity - Braden Scale Risk Assessment- Any patient with a Braden score =/<18 is at risk for skin breakdown Additional risk factors would be considered. For patients at risk, initiate skin integrity interventions. The Braden Scale Risk Assessment for pressure injuries would be performed on admission, every shift, and whenever a patient’s condition or level of care changes. a. Braden = 16-18: Low Risk. Initiate and implement Skin Integrity Interventions. b. Braden = 13-15: Moderate Risk. Initiate and implement Skin Integrity Interventions. Order waffle overlay for the mattress (unless using Stryker Isotour mattress, specialty mattress, or critical care mattress) and order waffle cushion for the chair. c. Braden = 12 or less: High risk. Automatic consult to Wound Care Specialist; nursing to implement Skin Integrity Interventions. GUIDELINES FOR SKIN BREAKDOWN: Skin breakdown consists of abrasions, blisters, lacerations, pressure injuries, rashes, redness, skin tears, and ulcers (arterial, diabetic, and venous). two RNs or one RN and one LPN to assess the patient’s skin on admission. Remove all dressings, assess wounds, clean wounds with normal saline or wound cleanser, and apply new dressing. Label dressing with date, time, and initials. RN to begin new wound site in Cerner under “Interactive View and I&O - Wound-Ostomy” on admission and when new wound occurs. Nursing to implement Skin Integrity Interventions for a Braden score of 18 or less. See Skin Integrity Interventions. Consult WOC Nurse (in Cerner - Consult to Wound Care Specialist) for pressure-related injuries and ostomy patients. WOC nursing is automatically consulted for a Braden score of 12 or less. A telephone interview took place in the facility’s office on 3/4/25 at 10:00 a.m. with Assistant Manager, Wound/Ostomy Care/Management (AMWO) CC, who stated that part of her duty was to work with all the wound care nurses to standardize processes for wound care practices. AMWO CC stated that the wound care nurses responded to consultations and assessed, stage, recommended care, and collaborated with other multidisciplinary teams if required to come up with a plan of care for the patient. AMWO CC stated that the nurses on the unit utilized the Braden score to initiate a set of protocol orders for patients, for example, a patient with a skin tear. AMWO further stated that a skin tear would not require a wound consultation as that can be taken care of at the bedside. A Zoom-call interview took place in the facility’s office on 3/4/25 at 10:30 a.m. with Registered Nurse (RN) DD, who stated she could not recall P#1. However, if a patient was at risk of developing a pressure injury on admission, protective measures such as offloading heels and pressure points would be put in place. RN DD stated that a wound care consultation would be put in if a fresh injury or wound was observed on a patient. An interview took place in the facility’s office on 3/4/35 at 11:00 a.m. with RN EE, who stated that she would put in a wound consultation for a patient if a pressure injury was noted. However, if the patient had a skin tear, a wound consultation may or may not be required depending on the location of the skin tear. RN EE stated that if the skin tear was on a pressure injury location, a wound consultation and an incident report would be done so staff could keep track of the wound to prevent deterioration. RN EE further stated that the facility made use of a “turn team” to ensure patients were turned as per protocol. An interview took place in the facility’s office on 3/4/25 at 11:30 a.m. with RN FF, who stated that if a patient had a possible pressure injury, he would report it to the charge nurse and the provider and also put in a wound consultation. RN FF stated that a turn list is populated based on the patient’s Braden score; however, patients were turned every two hours. RN FF stated that he could not recall P#1, however, it seemed P#1 always screamed whenever she was being turned. An interview took place in the facility’s office on 3/4/25 at 12:00 p.m. with Certified Wound Ostomy Nurse (CWON) GG, who stated that lack of turning interventions and reduced perfusion to the skin could cause a DTI (Deep Tissue Injury) on a patient. CWON GG stated that the wound care nurses see patients within 24-48 hours after receiving a consultation and assess the wound using measurements and descriptive narrative and also put in wound care orders for nurses to follow. CWON GG stated that wound photographs were not currently taken at the facility, and the staff only relied upon the measurements and wound description documented. CWON further stated that a protocol was in place for the prevention of pressure injuries and skin breakdown that nurses could follow depending on the patient’s Braden score. A Zoom-call interview took place in the facility’s office on 3/4/25 at 1:00 p.m. with RN HH, who stated that she received P#1 at about shift change, and during the skin assessments with RN DD, she did not think P#1 had any sores/injury on admission. RN HH stated that P#1 was on two-hourly turns and a HAPI bundle, which included offloading the heels and use of a waffle mattress. RN HH stated that if something suspicious was found, such as redness on a sacrum or any open wounds, especially on high-risk places such as the coccyx, a wound consultation would be put in. RN HH also stated that she was not quite sure if there was a set of protocols written out regarding wound care, but if she had any questions, she would ask the charge nurse. RN HH further stated that monthly meetings on HAPI prevention were done as well as annual skills day and HAPI bundle bootcamp. A telephone interview took place on 3/4/25 at 1:45 p.m. with RN II, who stated that the nurses and the patient care technicians work hand-in-hand to ensure patients are turned every two hours. RN II stated that if a patient refused turning, she would try to educate the patient on the implications and also inform the charge nurse. RN II stated that if a patient developed a deep tissue injury (DTI) not present on admission, an incident report would be done, and also a wound consultation. RN II also stated that hourly rounding was done where patients are checked to ensure they were being turned. A telephone interview took place on 3/4/35 at 2:15 p.m. with Patient Care Technician (PCT) JJ, who stated that she could not recall P#1. However, the staff did their best to ensure patients were being turned every two hours and pressure injury protective measures were in place. PCT JJ stated that the nurses also assist in turning of patients, and if the patient’s primary nurse was not available in assisting to turn a patient, the charge nurse will step in. PCT JJ also stated that if she noticed any wound/injury/sore on a patient, she would notify the nurse immediately. An interview took place in the facility’s office on 3/4/25 at 3:00 p.m. with Clinical Manager, PCU (CM) KK, who stated that she did a “SWARM” on P#1 when she received the incident report, which involved an extensive chart review and identifying opportunities for improvement. CM KK stated that during admission, P#1 had a two-nurse skin check, and she (P#1) was put on a turn-team rotation and had protective measures in place. CM KK stated that the outcome of the “SWARM” revealed minimal opportunities documenting the turns, and an action plan had been put in place.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 47718 Based on review of Governing Body Bylaws, medical records, policy and procedures and staff interviews it was determined that the facility’s Governing Body failed to ensure that physician orders were followed as ordered when one patient (P) (P#4) of four patients (P#1, P#2, P#3, and P#4) was reviewed. Specifically, the physician ordered P#4’s nasogastric (NG) tube to be set on low intermittent suction (used for removing gastric secretions from the stomach) and suction setting was found to be on continuous that resulted in nausea, vomiting, and blood loss for P#4. Findings included: A review of the facility ‘Bylaws’, effective 8/28/2019 revealed that in Article IV, section 4.7 titled ‘Responsibilities’ that the purpose of the Board was to govern the operation of the System and other facilities leased, constructed, operated or acquired by the Corporation. The responsibilities of the Board are to: (d) Evaluate all phases of System performance, including the quality of medical care and fiscal management. Cross-refer to A-0385 as it relates to the facility’s failure to provide patient care as ordered for P#4.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 47718 Based on the review of medical records, the facility’s policies/procedures, and staff interviews, the facility failed to follow physician orders for one patient (P) (P#4) of four patients (P#1, P#2, P#3, and P#4) reviewed. Specifically, the physician ordered P#4’s Nasogastric (NG) tube to be set on low intermittent suction (used for removing gastric secretions from the stomach) and suction setting was found to be on continuous that resulted in nausea, vomiting, and blood loss for P#4. Findings include: Cross- refer to A0392 as it relates to the facility’s failure to provide patient care as ordered to one patient (P#4) of four patients (P#1, P#2, P#3, and P#4) reviewed.”

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 47718 Based on the review of medical records, policy and procedures, and staff interviews, it was determined that the facility failed to follow physician orders of one patient (P#4) of four patients (P#1, P#2, P#3, and P#4) reviewed when it was determined that the Nasogastric (NG) tube (a thin, soft tube made of plastic or rubber that is passed through the nose, down through the throat, and into the stomach to deliver food, liquids, or medication) was on maximum continuous suctioning instead of low intermittent suctioning as ordered. Findings include: A review of the medical record revealed that P#4 was admitted to the facility on 8/29/24 at 7:52 a.m. with the diagnosis of abdominal pain secondary to a tubo-ovarian abscess (one of the late complications of pelvic inflammatory disease and can be life-threatening) and acute gastrointestinal (GI) bleeding (bleeding inside the intestinal tract). A review of the history and physical (H&P) dated 8/29/24 at 8:29 a.m. revealed that P#4 presented to the emergency room (ER) on 8/27/24 with findings consistent with enterocolitis (inflammation of the digestive tract), infection, or inflammation. P#4 was discharged home with loperamide (medication that can treat diarrhea), Zofran (medication that can prevent nausea and vomiting), and Levsin (medication to treat muscle cramps in the bowels or bladder). Continued review revealed that P#4 returned to the emergency room when symptoms persisted. Repeat diagnostic examination revealed an acute small bowel obstruction with a transition point in the upper pelvis (a medical condition where the small intestine is blocked). An order for Nasogastric (NG) Tube was entered by Emergency Department Physician (EDP) JJ on 8/29/24 at 5:09 a.m. The NG tube was placed by Registered Nurse (RN) GG on 8/29/24 at 6:10 a.m. in the Emergency Room (ER). A continued review of the medical record revealed that an X-ray (test using radiation to take pictures of the inside of the body) to confirm the placement of the NG tube was done on 8/29/24 at 7:30 a.m. Continued review revealed that RN EE contacted the physician on-call on 8/29/24 at 6:47 p.m. to confirm the NG tube needed to be on intermittent or continuous suctioning. Physician Assistant (PA) FF modified the NG tube order to include “ Low intermittent Suction “ on 8/29/24 at 7:15 p.m. Medical Doctor (MD) BB countersigned the order. A review of the gastroenterology consultation notes dated 9/2/24 at 5:10 p.m. revealed that P#4’s NG tube had been left on continuous suction, and P#4 had developed nausea, vomiting, and melena (black stools). Documentation also revealed that P#4 ‘s hemoglobin (a protein containing iron that facilitates the transportation of oxygen in red blood cells-for women healthy range 11.6 to 15 grams per deciliter) decreased from 9.3 the day prior to 7.6 that day. The plan was to repeat the hemoglobin level and continue NG suction at low intermittent suction. A review of the physician ‘s progress notes titled ‘Assessment/Plan’ on 9/5/24 at 6:19 p.m. revealed that the NG suction had been set to continuous at the maximum level for multiple hours prior to the morning on 9/2/24. On the morning of 9/2/2024, P#4 developed hematemesis (vomiting blood) and melena, and her hemoglobin decreased from 9.3 to 5.8. P#4 was transfused with two units of blood and the hemoglobin increased to 9.5. P#4 was discharged home on 9/10/24 at 7:45 p.m. with home health services. The discharge diagnoses included tubo-ovarian abscess, small bowel obstruction, gastric ulcer secondary to nasogastric (NG) tube trauma, and acute blood loss anemia. A review of the facility’s policy #11779 titled “Patient Assessment and Reassessment,” last revised 10/21/24, revealed that it was the policy of the facility to provide a standard approach throughout the organization (including inpatient and outpatient services) for patient assessment. The assessment included an evaluation of the patient ’ s relevant physical, psychological, and social status. Reassessment: 1. Each patient was reassessed at regularly specified times related to the patient’s course of treatment. The objective of the reassessment was to ensure that the patient’s status is periodically reviewed so care decisions remain appropriate. 2. A reassessment will occur when there is a significant change in the patient’s condition or when a significant change occurs in the patient’s diagnosis. 3. Reassessment will be documented in the medical record. 4. The time of assessment will be reflected in the medical record. 5. If the patient’s direct caregiver is an LPN, the RN with assigned oversight will review the shift assessment and reassessment. A review of the facility ‘s policy #29522 titled “Nasogastric (NG), Orogastric (OG), Enteric Feeding Tube,” last revised 1/15/24 revealed the following: Nurses may insert and remove large-bore nasogastric, and orogastric tubes for gastric decompression with a physician order. a. Nurses would make a reasonable effort to insert the nasogastric tube, with a recommended maximum of two attempts. The total limit of attempts at insertion to four. Nurses may remove enteric feeding tubes or large bore nasogastric tubes as directed by physician order. Placement of NG, OG, or enteric tubes in esophageal or bariatric surgery patients will follow the hospital policy of obtaining an order for and ensuring confirmation by X-ray. NG, OG, or enteric tubes may be removed from esophageal or gastric surgery patients by a nurse with a physician’s order. Large bore NG tube or Orogastric tube insertion: Nurses will verify an order has been placed for a confirmation x-ray of placement following tube insertion. This pertains to insertion with or without the placement device. A nasogastric tube or orogastric tube for decompression may be immediately connected to suction prior to the x-ray confirmation of placement. No medications, flushes, or feedings may be administered through the tube without X-ray confirmation. Nurses will refer to the physician’s order for instructions related to the use of the tube following insertion (i.e. suction, gravity, clamp, etc.) after confirmation of placement is obtained. An interview took place in the facility ‘s conference room on 12/3/24 at 9:00 a.m. with the Nursing Emergency Department Director (NED) AA who stated that the order for a Nasogastric (NG) tube for P#4 was entered on 8/29/24 at 5:00 a.m. and the NG tube was inserted on 8/29/24 at 6:10 a.m. in the Emergency room (ER) before P#4 was transferred to the floor. During a telephone interview on 12/3/24 at 9:55 a.m. with Medical Doctor (MD) BB, stated that in most cases, routine management for an NG tube would be put on intermittent suction. MD BB stated that he was probably on call the day P#4 was admitted to the facility as he (MD BB) cosigned the NG tube order. PA FF modified for P#4. An interview took place in the facility ‘s conference room on 12/3/24 at 10:15 a.m. with Chief Nursing Officer (CNO) CC who stated that she was not aware of P#4 ‘s incident. CNO CC stated that generally, hand-off was usually done at the bedside and that might have been when incorrect suction setting was observed. CNO CC explained that nurses receive training to ensure competency in NG tube insertion and management. A telephone interview took place on 12/3/24 at 10:45 a.m. with Registered Nurse (RN) EE who stated that nurses were required to follow doctor ‘s orders, and the doctor was required to chart in an NG tube order if the suctioning was to be intermittent or continuous. RN EE stated that if there was an omission on the doctor ‘s part, the doctor would be contacted to clarify the order. RN EE stated that she could not recall P#4. A telephone interview took place on 12/3/24 at 11:00 a.m. with Physician Assistant (PA) FF who stated that he only met P#4 once, and did not follow P#4’s case because he (PA FF) was not assigned to round on her. PA FF stated that the NG tube was placed for decompression, and he (PA FF) modified the order placed by EDP JJ by adding that the NG tube should be on low intermittent suction. PA FF also stated that usually the only time suction was placed on continuous suction would be with a chest tube because if a continuous suction was placed on the bowel, it could possibly lead to an ulcer. An interview took place in the facility ‘s conference room on 12/3/24 at 11:20 a.m. with RN GG who stated that she was the charge nurse on duty the day P#4 was admitted to the emergency room. RN GG stated that the doctor had ordered an NG tube, and she (RN GG) went to insert the NG tube, and an X-ray was done at P#4 ‘s bedside to confirm placement. RN GG explained that it was part of the protocol to put an NG tube on low intermittent suction unless otherwise ordered by the doctor. During an interview with Charge Nurse/Supervisor (CN) HH in the facility ‘s conference room on 12/3/24 at 11:40 a.m. CN HH explained that nurses round on all patients during hand-off. CN HH recalled that the primary nurse for P#4 and a doctor informed her that P#4’s NG suction was found on maximum continuous instead of low intermittent. CN HH stated that the doctor ordered labs, and (CN HH) tried to reassure P#4 and P#4’s family. CN HH recalled that shortly after, P#4’s family member reported that P#4 was vomiting blood and passing bloody stools. CN HH stated that the NG suction was turned off as it was clogged with blood and the rapid response team was called. P#4 was transferred to an intermediate care unit for one-to-one observation. CN HH explained that nurses were required to monitor an NG tubes output every four hours. CN HH recalled that the oncoming nurse RN LL confirmed that the NG canister was filled with blood after hand-off around 7:30 a.m. A telephone interview took place on 12/3/24 at 12:45 p.m. with Emergency Department (ED) Physician (EDP) JJ who recalled that she ordered an NG tube insertion for P#4 because (P#4) was in a lot of pain. She further stated that NG tubes were usually placed on low intermittent suction. EDP JJ stated that a potential complication of any NG tube was an ulcer regardless of the suction setting. EDP JJ also stated that patients were always educated on the pros and cons of having an NG tube. During a telephone interview on 12/3/24 at 2:50 p.m. with RN LL recalled getting hand-off from RN II. She stated that the bedside hand-off was done in the hallway because P#4 had requested for the lights to be turned off because (P#4) wanted to sleep. RN LL stated that she did not turn on the light but she checked the intravenous line and the NG tube, which was flowing. RN LL recalled that later in the morning, she observed that the NG suction was on maximum continuous. RN LL stated that the doctor walked in at the same time and educated P#4 and her family about why the canister contained a little blood. RN LL also stated that the suction was not functioning properly as the aerator was clogged with blood, which triggered P#4 to cough up blood. P#4 was transferred to the intermediate care unit for one-to-one observation.”

“COMPLIANCE WITH LAWS CFR(s): 482.11(a) The hospital must be in compliance with applicable Federal laws related to the health and safety of patients. This Standard is not met as evidenced by: 49398 Based on a review of facility policy and procedures, state and federal codes, a logbook, medical record request form, and staff interviews, it was determined that the facility failed to comply with state and federal laws related to granting immediate access upon reasonable request to review medical records. Specifically, the facility failed to: 1. Fulfill a medical records request made by the Department of Community on 11/27/24 for the purpose of a Center for Medicare and Medicaid Services authorized complaint investigation. 2. To provide a written explanation of why the request could not be fulfilled within 24 hours. 3. To record the request in the medical records request log. This non-compliance resulted the initiation of an on-site investigation and delayed the survey process. Findings include: A review of the facility’s policy titled “Privacy and Confidentiality of Patient Information,” #A-019, last revised 10/28/08, revealed that the policy’s purpose was to assure health information privacy and confidentiality for all patients receiving services at the facility while permitting appropriate information disclosure to accomplish patient care and other organizational objectives. E. PERMITTED USES AND DISCLOSURE OF PHI WITHOUT PATIENT AUTHORIZATION 4. Mandatory Reports. PHI may be released without a patient’s written authorization, where reporting is required by state or federal law after consultation with the facility’s privacy officer or legal services department. The facility may also release PHI to a health oversight agency for activities authorized under law after consultation with the facility Privacy Officer or Legal Services Department. 9. Requests Made in Connection with Public Health. Northside may use or disclose PHI (ii) to a public health authority or other appropriate government authority authorized by law to receive reports of child abuse or neglect. Such requests must be referred to the HIM Department for release, which will notify or consult with the Risk Management Department or Legal Services Department as necessary prior to releasing PHI. 15. Other Requests for Disclosure. This Policy addresses the most common situations in which disclosure of PHI is requested. Disclosure of PHI may be permitted upon approval by the facility’s Legal Services Department, Compliance Department, or Risk Management Department in other less common circumstances (i.e., national security). Any request for disclosure not specifically identified above should be referred to the facility’s Legal Services Department or Risk Management Department for evaluation under applicable state and federal laws. H. PATIENT RIGHTS UNDER HIPAA Patients may exercise their HIPAA rights regarding their PHI through the following procedures and using the attached Privacy and Confidentiality of Patient Information Forms. d. Third Party Requests to Receive Patient Records. If any third party (someone other than the patient) would be the recipient of the medical records, the patient must complete the facility-approved Authorization form prior to the release of the patient’s medical records to a third party. The Northside HIM Department (or an approved facility medical record processing vendor) will review the request, verify the patient’s identity, consult as needed with the facility Risk Management Department or Legal Services Department, and respond promptly to the requestor within thirty (30) days. If an extension is necessary, the requesting individual must be notified in writing and provided with the reason for the delay and the anticipated date of response. In the event Northside chooses to deny an individual access to his/her record, it must review that determination with the Legal Services Department or Chief Compliance Officer. If Northside elects to deny a request, written notice must be provided to the requestor in plain language of this decision and inform the requestor of their right to have the decision reviewed and how to request such a review. The requestor must also be informed about their right to complain to Northside or HHS. All requests for such a review should be referred to the Legal Services Department or Chief Compliance Officer for evaluation. A review of federal regulation Title 42: Public Health “PART 1001-PROGRAM INTEGRITY-MEDICARE AND STATE HEALTH CARE PROGRAMS,” last revised 1/12/17, revealed that: Subpart C-Permissive Exclusions §1001.1301 Failure to grant immediate access. (a) Circumstance for exclusion. (1) The OIG may exclude any individual or entity that fails to grant immediate access upon reasonable request to- (i) The Secretary, a State survey agency, or other authorized entity for the purpose of determining, in accordance with section 1864(a) of the Act, whether- (A) An institution is a hospital or skilled nursing facility; (ii) The Secretary, a State survey agency or other authorized entity to perform the reviews and surveys required under State plans in accordance with sections 1902(a)(26) (relating to inpatient mental hospital services), 1902(a)(31) (relating to intermediate care facilities for individuals with intellectual disabilities), 1919(g) (relating to nursing facilities), 1929(i) (relating to providers of home and community care and community care settings), 1902(a)(33) and 1903(g) of the Act; (iii) The OIG for reviewing records, documents, and other material or data in any medium (including electronically stored information and any tangible thing) necessary to the OIG’s statutory functions; or (iv) A State Medicaid fraud control unit for the purpose of conducting its activities. (2) For purposes of paragraphs (a)(1)(i) and (a)(1)(ii) of this section, the term- Failure to grant immediate access means the failure to grant access at the time of a reasonable request or to provide a compelling reason why access may not be granted. Reasonable request means a written request made by a properly identified agent of the Secretary, of a State survey agency or of another authorized entity, during hours that the facility, agency or institution is open for business. The request will include a statement of the authority for the request, the rights of the entity in responding to the request, the definition of reasonable request and immediate access, and the penalties for failure to comply, including when the exclusion will take effect. (3) For purposes of paragraphs (a)(1)(iii) and (a)(1)(iv) of this section, the term- Failure to grant immediate access means- (i) The failure to produce or make available for inspection and copying the requested material upon reasonable request or to provide a compelling reason why they cannot be produced, within 24 hours of such request, except when the OIG or State Medicaid Fraud Control Unit (MFCU) reasonably believes that the requested material is about to be altered or destroyed, or (ii) When the OIG or MFCU has reason to believe that the requested material is about to be altered or destroyed, the failure to provide access to the requested material at the time the request is made. Reasonable request means a written request, signed by a designated representative of the OIG or MFCU and made by a properly identified agent of the OIG or an MFCU during reasonable business hours, where there is information to suggest that the person has violated statutory or regulatory requirements under Titles V, XI, XVIII, XIX, or XX of the Act. The request will include a statement of the authority for the request, the person’s rights in responding to the request, the definition of “reasonable request” and “failure to grant immediate access” under part 1001, and the effective date, length, and scope and effect of the exclusion that would be imposed for failure to comply with the request, and the earliest date that a request for reinstatement would be considered. (4) Nothing in this section shall in any way limit access otherwise authorized under State or Federal law. (b) Length of exclusion. (1) An exclusion of an individual under this section may be for a period equal to the sum of: (i) The length of the period during which the immediate access was not granted, and (ii) An additional period of up to 90 days. (2) The exclusion of an entity may be for a longer period than the period in which immediate access was not granted based on consideration of the following factors- (i) The impact of the failure to grant the requested immediate access to Medicare or any of the State health care programs, beneficiaries, or the public; (ii) The circumstances under which such access was refused; (iii) The impact of the exclusion on Medicare, Medicaid, or any of the other Federal health care programs, beneficiaries, or the public; and (iv) Whether the entity has a documented history of criminal, civil, or administrative wrongdoing (The lack of any prior record is to be considered neutral). (3) For purposes of paragraphs (b)(1) and (b)(2) of this section, the length of the period in which immediate access was not granted will be measured from the time the request is made or from the time by which access was required to be granted, whichever is later. (c) The exclusion will be effective as of the date immediate access was not granted. [57 FR 3330, Jan. 29, 1992, as amended at 58 FR 40753, July 30, 1993; 63 FR 46689, Sept. 2, 1998; 64 FR 39427, July 22, 1999; 82 FR 4115, Jan. 12, 2017] A review of “Official Code of Georgia TITLE 31 Health (Ch’s. 1 - 54) CHAPTER 2 Department of Community Health (55 31-2-1 - 31-2-20)” last amended 2021, revealed that: 31-2-8. Actions against certain applicants or licensees. (a) This Code section shall be applicable to any agency, center, facility, institution, community living arrangement, drug abuse treatment, and education program, or entity subject to regulation by the department under Chapters 7, 13, 22, 23, and 44 of this title; Chapter 5 of Title 26; paragraph (8) of subsection (d) of Code Section 31-2-4; and Article 7 of Chapter 6 of Title 49. For purposes of this Code section, the term “license” shall be used to refer to any license, permit, registration, or commission issued by the department pursuant to the provisions of the law cited in this subsection. (b) The department shall have the authority to take any of the actions enumerated in subsection (c) of this Code section upon a finding that the applicant or licensee has: 1. Failed or refused to provide the department with access to the premises subject to regulation or information pertinent to the initial or continued licensing of the agency, facility, institution, or entity; 2. Failed to comply with the licensing requirements of this state; or 3. Failed to comply with any provision of this Code section. (c) When the department finds that any applicant or licensee has violated any provision of subsection (b) of this Code section or laws, rules, regulations, or formal orders related to the initial or continued licensing of the agency, facility, institution, or entity, the department, subject to notice and opportunity for hearing, may take any of the following actions: 1. Refuse to grant a license; provided, however, that the department may refuse to grant a license without holding a hearing prior to taking such action; 2. Administer a public reprimand; 3. Suspend any license for a definite period or for an indefinite period in connection with any condition which may be attached to the restoration of said license; (5) Revoke any license; 1. Except as otherwise provided in subparagraph (B) of this paragraph, impose a fine of up to $2,000.00 per day for each violation of a law, rule, regulation, or formal order related to the initial or ongoing licensing of any agency, facility, institution, or entity, up to a total of $40,000.00; 2. Impose a mandatory fine of no less than $5,000.00 for a violation of a law, rule, regulation, or formal order related to the initial or ongoing licensing of a long-term care facility which has caused the death of or serious physical harm to a resident in such facility. For purposes of this subparagraph, the term “serious physical harm” means an injury which causes any significant impairment of the physical condition of the resident as determined by qualified medical personnel. (g) The department shall have the authority to make public or private investigations or examinations inside or outside of this state to determine whether the provisions of this Code section or any other law, rule, regulation, or formal order relating to the licensing of any agency, facility, institution, or entity has been violated. Such investigations may be initiated at any time, at the discretion of the department, and may continue during the pendency of any action initiated by the department pursuant to subsection (c) of this Code section. 1. For the purpose of conducting any investigation, inspection, or survey, the department shall have the authority to require the production of any books, records, papers, or other information related to the initial or continued licensing of any agency, facility, institution, or entity. 2. Pursuant to the investigation, inspection, and enforcement powers given to the department by this Code section and other applicable laws, the department may assess against an agency, facility, institution, or entity reasonable and necessary expenses incurred by the department pursuant to any administrative or legal action required by the failure of the agency, facility, institution, or entity to fully comply with the provisions of any law, rule, regulation, or formal order related to the initial or continued licensing. A review of the Medical Records Request log dated 5/1/24 through 12/17/24 failed to reveal an entry made for P#1’s medical records on 11/27/24 by the Department of Community Health. A review of a medical record request by the Department of Community Health, dated 11/27/24, revealed that it was sent to the facility on 11/27/24. During an interview on 12/17/24 at 4:15 p.m., with System Director (SM) AA, SM AA explained that a third-party vendor receives medical record requests and is responsible for validating the requestor’s information and the patient’s medical record information. Once the information is verified, the vendor will forward the request to the facility’s Hospital Information System (HIS) Department to release the record. SM AA said that when a request is fulfilled or denied, it is logged into the medical records request log and should never be left off the logbook. Once verified and forwarded to the facility’s HIS department, medical records requests will be released within ten or more business days. SM AA added that she expects the Department of Community Health and the Centers for Medicare and Medicaid Services to follow the process she described when requesting medical records and if all of the information required to release a medical record is not provided when the Department of Community Health and the Centers for Medicare and Medicaid Services requests it, the request for medical records will be denied. SM AA further explained that if a record request is received by a facility staff member who works outside of the HIS department, she expects the request to be forwarded to the HIS department for verification and processing. A telephone interview was conducted on 12/18/24 at 1:00 p.m. with Medical Records Custodian (MRC) CC. MRC CC explained that she is an employee of a medical records vendor contracted by the facility and that she is responsible for overseeing the timely completion of medical record requests for several facility campuses. MRC CC explained that all requests are entered into the medical records request log. She added that she was unsure why the state’s request was not entered into the logbook but that 98 percent (%) of the log is accurate. She added that they try to prioritize state and federal agency requests, but she is unaware of any exclusions that apply to a state survey agency or other agencies for performing reviews and surveys requiring immediate access to medical records. A follow-up telephone interview with SM AA was conducted on 12/18/24 at 1:15 p.m. SM AA explained that the contracted medical records vendor audits medical records requests and will forward reports for the facility to review but that the facility does not provide direct oversight of the medical records requests. She added that she is unaware of any exclusions that apply to a state survey agency or other agencies for performing reviews and surveys requiring immediate access to medical records.”

“STANDING ORDERS FOR DRUGS CFR(s): 482.23(c)(1)(ii ),(c)(3) & (c)(3)(iii) (ii) Drugs and biologicals may be prepared and administered on the orders contained within pre-printed and electronic standing orders, order sets, and protocols for patient orders only if such orders meet the requirements of §482.24(c)(3). (3) With the exception of influenza and pneumococcal vaccines, which may be administered per physician-approved hospital policy after an assessment of contraindications, orders for drugs and biologicals must be documented and signed by a practitioner who is authorized to write orders in accordance with State law and hospital policy, and who is responsible for the care of the patient as specified under §482.12(c) ... This Standard is not met as evidenced by: 47718 Based on review of medical records, policy and procedure, and staff interviews, it was determined that the facility failed to administer on the orders contained within an electronic standing orders, order sets, and protocols for patient orders of one patient (P)#1 out of six sampled patients by not titrating a blood pressure medication as per order to help manage P#1’s blood pressure. Findings: A review of Patient (P)#1’s medical record revealed that P#1 was admitted to the facility on 10/26/23 at 1:24 p.m. via the emergency department with the chief complaint of Altered Mental Status. P#1’s blood pressure on arrival was 197/99 mmHg. A review of the History and Physical (H&P) revealed that P#1’s blood pressure at 1:44 p.m. was 219/99 mmHg, and Hydralazine (medication to treat high blood pressure) was given intravenously (via the vein) at 1:44 p.m. At 1:47 p.m., P#1’s blood pressure was 206/94 mmHg. At 1:49 p.m., P#1’s blood pressure was 207/102 mmHg. P#1 had a Computed Tomography (CT) Scan of the head (a procedure to help detect internal bleeding) at 1:10 p.m. and a Neurological consultation, which confirmed that there was no acute bleeding in the brain, and P#1 was diagnosed with Acute Ischemic Stroke (occurs when the blood supply to part of the brain is interrupted or reduced, preventing the brain tissue from getting oxygen and nutrients). Documentation of the physician orders at 1:42 p.m. revealed an order of Nicardipine (a medication that treats high blood pressure) to be titrated by 2.5 mg/hr with a titration maximum of 15 mg/hr. Documentation revealed that P#1’s systolic blood pressure was to be maintained within the range of 160 to 179 mmHg, and the diastolic between 90 to 104 mmHg. Documentation revealed the infusion was to be initiated if the Systolic blood pressure was greater than/equal to 180 mmHg, or if the diastolic was greater than/equal to 105 mmHg. A review of the physician orders revealed an order for Tissue Plasminogen Activator (tPA, Activase, Alteplase- a medication that facilitates the breakdown of blood clots) on 10/26/23 at 1:52 p.m. Documentation of the medication administration record (MAR) on 10/26/23 revealed that the Nicardipine infusion was initiated at 1:59 p.m. at the rate of 5 mg/hr. P#1’s blood pressure was 198/91 mmHg at 1:58 p.m. At 2:01 p.m., P#1’s blood pressure was 174/77 mmHg. At 2:05 p.m., P#1’s blood pressure was 174/77 mmHg. At 2:06 p.m., P#1’s blood pressure was 156/72 mmHg. A review of the medication administration record on 10/26/23 revealed that Alteplase bolus was administered at 2:07 p.m. and the Alteplase infusion at 2:08 p.m. P#1’s blood pressure at 2:11 p.m. was 181/84 mmHg. Documentation under the physician progress notes on 10/26/23 revealed that a repeat CT scan was done at 2:49 p.m., which revealed no acute bleeding. Documentation under the medication administration record revealed that the tPA infusion was stopped at 3:10 p.m. At 2:20 p.m., P#1’s blood pressure was 192/86 mmHg. At 2:30 p.m., P#1’s blood pressure was 197/89 mmHg. At 2:41 p.m., P#1’s blood pressure was 135/73 mmHg. At 2:55 p.m., P#1’s blood pressure was 133/77 mmHg. At 3:10 p.m., P#1’s blood pressure was 160/90 mmHg. At 3:20 p.m., P#1’s blood pressure was 165/77 mmHg. At 3:25 p.m., P#1’s blood pressure was 164/85 mmHg. At 3:40 p.m., P#1’s blood pressure was 185/89 mmHg. At 4:00 p.m., P#1’s blood pressure was 175/80 mmHg. At 4:08 p.m., P#1’s blood pressure was 197/91 mmHg. At 4:15 p.m., P#1’s blood pressure was 198/89 mmHg. A review of the nursing progress notes revealed that P#1 was transferred to the intensive care unit on 10/26/23 at 4:30 p.m. as per the facility’s protocol. P#1’s blood pressure was 180/78 mmHg at the time of transfer. At 4:45 p.m., P#1’s blood pressure was 175/85 mmHg. At 5:00 p.m., P#1’s blood pressure was 179/84 mmHg. At 5:15 p.m., P#1’s blood pressure was 169/79 mmHg. At 5:30 p.m., P#1’s blood pressure was 156/74 mmHg. At 5:45 p.m., P#1’s blood pressure was 161/72 mmHg. At 6:00 p.m., P#1’s blood pressure was 173/77 mmHg. At 6:15 p.m., P#1’s blood pressure was 176/81 mmHg. At 6:33 p.m. and 6:36 p.m., P#1’s blood pressure was 178/86 mmHg. At 6:45 p.m., P#1’s blood pressure was 214/101 mmHg. Documentation failed to reveal that the Nicardipine infusion was titrated as per the physician orders from 1:59 p.m. to 7:00 p.m. Documentation under the physician progress notes revealed an order for a CT scan on 10/26/23 at 6:22 p.m., however, documentation revealed that P#1’s heart rate dropped while being transferred for CT, and had to be taken back to the Intensive Care Unit (ICU) to be intubated (insertion of a tube through the airway so that air can get through) at 6:54 p.m. Documentation under the medication administration record (MAR) on 10/26/23 revealed that the next titration of the nicardipine was done at 7:00 p.m. at the rate of 10 mg/hr. P#1’s blood pressure was 152/101 mmHg. At 7:05 p.m., the titration was at 12.5mg/hr. P#1’s blood pressure was 164/79 mmHg. At 7:27 p.m., the titration was decreased to 10 mg/hr. P#1’s blood pressure was 160/77 mmHg. At 7:30 p.m., titration was reduced to 7.5 mg/hr. No blood pressure documentation. At 7:32 p.m., the titration was reduced to 5 mg/hr. P#1’s blood pressure was 155/85 mmHg. At 7:50 p.m., the titration was decreased to 2.5 mg/hr. P#1’s blood pressure was 152/73 mmHg. At 7:55 p.m., the titration was stopped. P#1’s blood pressure was 140/74 mmHg. At 8:32 p.m., P#1’s blood pressure dropped to 88/59 mmHg. At 9:30 p.m., P#1’s blood pressure was 163/79 mmHg. At 10:02 p.m., P#1’s blood pressure was 180/88 mmHg. At 10:15 p.m., P#1’s blood pressure was 99/52 mmHg. At 10:30 p.m., P#1’s blood pressure was 184/103 mmHg. At 11:15 p.m., P#1’s blood pressure was 108/61 mmHg. On 10/27/23 at 6:02 a.m., P#1’s blood pressure was 82/50 mmHg. At 10:02 a.m., P#1’s blood pressure was 127/66 mmHg. At 1:02 p.m., P#1’s blood pressure was 121/60 mmHg. P#1 expired on 10/27/23 at 2:55 p.m. P#1’s family notified. A review of the facility’s policy titled “Medical Administration” policy # F-027, last revised 10/17/22, revealed that the professional care nurse was responsible for the administration and documentation of medications. A review of the facility’s policy titled “Medication Order Types” policy # 23763, last revised 10/09/23 revealed that titrating orders were orders in which the dose was progressively increased or decreased in response to the patient’s status (Common examples: critical care infusions, dopamine, lorazepam). If a patient required multiple titratable infusions for the same clinical indication and/or clinical endpoint, the most recently ordered infusion would take priority in being titrated unless specifically ordered otherwise by the provider. A review of the facility’s policy titled “Assessment and Documentation of the Emergency Department Patient” policy # 6902-36, last revised 2/2023 revealed it was the policy of Northside Hospital Gwinnett Emergency Services to assess all patients. The assessment began with triage and progressed through the initial assessment, ongoing reassessment and through the patient’s final disposition. Further review revealed reassessments would occur if the patient was unstable, defined as having abnormal vital signs, receiving medications titrated for effect, receiving fluid boluses, or by deterioration in condition. An interview took place in the conference room on 11/13/23 at 4:16 p.m. with Director, Neuroscience (DN) DD who stated that the staff administered the tPA to P#1 once she (P#1) exhibited stroke-like symptoms and the CT head confirmed there was no hemorrhage. DN DD stated that the tPA was administered within the window period to prevent complications from the stroke. A telephone interview took place in the conference room on 11/14/23 at 10:35 a.m. with Nurse Practitioner (NP) FF who stated that P#1 was admitted to the intensive care unit (ICU) for the post tPA pathway as per protocol. NP FF stated that P#1 declined in mental status while waiting on CT, and she (P#1) became hemodynamically unstable (abnormal or unstable blood pressure). NP FF stated that she reported to the physician and updated P#1’s treatment plan. A telephone interview took place in the conference room on 11/14/23 at 11:00 a.m. with Clinical Supervisor (CS) HH who stated that tPA bolus was usually given at the Emergency department (ED), and the medication is managed by the pharmacy. CS HH stated that patients are received in the intensive care unit (ICU) after the bolus and the physician orders are strictly followed. A telephone interview took place in the conference room on 11/14/23 at 2 p.m. with Registered Nurse (RN) II who stated that staff always made sure vitals were checked during tPA administration. RN II stated that when she noticed P#1 was coughing up blood, she (RN II) notified the physician who ordered an intravenous dose of Pepcid (medication to treat acid reflux), which was given. RN II stated that she could not recall if P#1 was on a cardiac infusion and if she (P#1) had any other anti-hypertensive medication. A telephone interview took place in the conference room on 11/14/23 at 2:30 p.m. with Medical Doctor (MD) JJ who stated that any patients on tPA are admitted to the intensive care unit as per the stroke protocol. MD JJ stated that P#1 was on a Nicardipine drip (medication used to treat high blood pressure), and the blood pressure would not go down if the medication was not titrated as per order. A telephone interview took place on 11/14/23 at 4:30 p.m. with Registered Nurse (RN) BB who stated that she could not recall if P#1 was on an infusion. RN BB stated that if a patient was on a Nicardipine drip, the medication would be titrated off the order parameters. RN BB further stated she could not recall if P#1 was on Nicardipine infusion.”