Fmc - Bma of Warner Robins

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 52051 Based on a review of facility records, patient representative and staff interviews, a review of the National Institute of Health (NIH) guidelines, and a review of the facility’s Policies and Procedures (P & P), it was determined that the Medical Director failed to ensure that two of two Registered Nurses (RN AA and RN BB) performed pre-assessment and post-assessment of Patient (P) #1 respectively, relative to a post-fall incident on July 25, 2025 at the Patients’ Weighing Scale, and failure to offer an assistive device such as a wheelchair to prevent exacerbation of potential injury to P#1’s knees following the fall incident before and after hemodialysis treatment, and failure of one of one Patient Care Techinician (PCT AA) and one of one Licensed Practical Nurse (LPN AA), to address post-fall assessment during the 30-minute intradialytic monitoring. Additionally, the Medical Director failed to ensure the facility’s P & P relative to “Patient Safety Event Reporting and Documentation”, “Patient Assessment and Monitoring”, “Nursing Supervision and Delegation Standards”, and “Medical Record Documentation Standards”, were implemented and adhered to. This deficient practice had the potential to negatively impact the health and safety of P#1 (transient) and all the other 76 in-center hemodialysis (ICHD) patients (non-transient), who were under the care of this facility. Findings include: Cross Reference: V715 - Failure of the Medical Director to ensure Direct Patient Care (DPC) Staff (nurses and patient care technicians) implemented and adhered to facility Policies and Procedure (P&P) relative to a fall incident that occurred at the facility’s Weighing Scale on 7/25/25, involving P#1.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 52051 Based on observation, staff interviews, and a review of records, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 76 in-center hemodialysis (ICHD) patients who were currently receiving dialysis services at this facility. Cross Reference: V715 - Failure of the Medical Director to ensure Direct Patient Care (DPC) Staff (nurses and patient care technicians) implemented and adhered to facility Policies and Procedure (P&P) relative to a fall incident that occurred at the facility’s Weighing Scale on 7/25/25, involving P#1.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 52051 Based on observation, patient representative and staff interviews, and a review of facility records, it was determined that the facility failed to ensure there was a safe environment for all patients and staff that was free of physical hazards, as evidenced by an uneven surface between the Patients’ Weighing Scale and Patient Treatment Room floor, without a Precautionary Signage to alert patients and Direct Patient Care (DPC) staff (nurses and patient care technicians) of the uneven surface area. This failure presented a risk for trips and falls that negatively affected the health and safety of Patient (P) #1, who was a transient patient. This environmental concern was observed in one of one Patient Treatment Room. The facility had 76 (non-transient) in-center hemodialysis (ICHD) patients. Findings include: During observation in the Patient Treatment Room on 7/30/25 between 8:15 a.m. and 9:15 a.m., it was revealed that the Patients’ Weighing Scale was not at the same level with the Patient Treatment Room’s floor surface level. The Patients’ Weighing Scale was a quarter of an inch lower than floor level and there was no Precautionary Signage to alert and warn patients while using the Patients’ Weighing Scale, regarding the uneven floor level. A review of “Adverse Occurrence Report (AOR)” for the last six months (February 2025 - July 2025) revealed the following: - One of five fall incidents (between February 2025 and July 2025), occurred at the Patients’ Weighing Scale involving P#1, while weighing before her treatment on 7/25/25. During an interview with P#1’s representative (family member), on 7/30/25, at 9:28 a.m., she stated that P#1 had fallen at the facility on 7/25/25 while weighing at the Patients’ Weighing Scale due to an uneven surface... During an interview with Patient Care Technician (PCT AA), on 7/30/25, at 1:49 p.m., she stated that she was washing her hands when she witnessed P#1’s fall at the weighing scale with the Administrative Assistant (Staff AA) next to P#1. A review of P#1’s “Treatment Sheet” dated 7/25/25 showed under Multidisciplinary Notes: - Registered Nurse (RN) called and informed the Medical Director of P#1, “tripping on raised area on scale while weighing...” Signed by RN AA at 12:44 p.m. For additional information, Cross Reference V 715 - Failure of the Medical Director to ensure Direct Patient Care (DPC) Staff (nurses and patient care technicians) implemented and adhered to facility Policies and Procedures for patient safety.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 52051 Based on a review of facility records, patient representative and staff interviews, a review of the National Institute of Health (NIH) guidelines, and a review of the facility’s Policies and Procedures (P & P), it was determined that the Medical Director failed to ensure that two of two Registered Nurses (RN AA and RN BB) performed pre-assessment and post-assessment of Patient (P) #1 respectively, relative to a post-fall incident on July 25, 2025 at the Patients’ Weighing Scale, and failure to offer an assistive device such as a wheelchair to prevent exacerbation of potential injury to P#1’s knees following the fall incident before and after hemodialysis treatment, and failure of one of one Patient Care Techinician (PCT AA) and one of one Licensed Practical Nurse (LPN AA), to address post-fall assessment during the 30-minute intradialytic monitoring. Additionally, the Medical Director failed to ensure the facility’s P & P relative to “Patient Safety Event Reporting and Documentation”, “Patient Assessment and Monitoring”, “Nursing Supervision and Delegation Standards”, and “Medical Record Documentation Standards”, were implemented and adhered to. This deficient practice had the potential to negatively impact the health and safety of P#1 (transient) and all the other 76 in-center hemodialysis (ICHD) patients (non-transient), who were under the care of this facility. Findings include: A review of P#1’s “Treatment Sheet” dated 7/25/25, revealed the following, in order: Pre-dialysis Vitals and Evaluation: New complaints or new observations since last treatment (including fall or injury): “No new findings”, dated and signed by PCT AA at 11:59 a.m. Treatment Data: Dialysis treatment started at 12:10 p.m., and signed by PCT AA. Multidisciplinary Notes: 7/25/25 12:44 “RN (RN AA) calls and informs (name of Medical Director - MD) of pt (P#1) tripping on raised area of scale while weighing and of pt (P#1) going down on area below left knee. Ice pack applied; pt. (P#1) voices no c/o (complaint)”. (sic) 7/25/25 12:47 - “12:38 RN (RN AA) calls and informs (name of MD), of pt. (P#1) tripping on raised area of floor scale while weighing and going down on area below left knee. Ice pack applied; pt. (P#1) voices no c/o. Omit duplicate note”. (sic) 7/25/25 13:02 - “RN (RN AA) calls the covering clinic mgr (manager), (name of clinic manager - CM/RN) and informs her that after the pt. (P#1) finished weighing, she tripped on the raised area of the scale and went down on the area below her left knee. No injury noted to area; ice pack placed; and (name of MD) informed”. (sic) Nursing Evaluation: Evaluation: 07/25/25 12:04 (Pre-treatment): Ambulation Status - “Ambulates (walks) w/o (without) assistance”. General Overview - “No complaint” Note - “RN Evaluation - No Unusual findings noted”. Signed by RN AA. Evaluation: 7/25/25 16:50 (Post-treatment): Ambulation Status - “Ambulates w/o assistance”. General Overview - “No complaint”. Note - “RN Evaluation - No unusual findings noted”. Notes: “Patient (P#1) tolerated treatment well. VSS (vital signs stable) and LOC (level of consciousness) good at end of treatment. Treatment terminated with no complications”. Signed by RN BB at 16:50 (4:50 p.m.). The treatment records failed to reveal documentation indicating that a pain assessment had been conducted after the fall incident, even though the AOR stated that P#1 had complained of pain initially. Additionally, the records failed to reveal an assessment and continued monitoring by PCT AA and LPN AA during P#1’s hemodialysis treatment. The records also lacked documentation showing that RN AA and RN BB had re-assessed or re-evaluated P#1 related to the fall incident and there were no additional orders from the Medical Director, for further evaluation, such as sending P#1 for an X-ray of the affected area, after being notified of the fall. Furthermore, the records failed to reveal documentary evidence that P#1 was offered a wheelchair as a precautionary measure to prevent potential exacerbation of a possible knee injury. A review of the facility’s “Adverse Occurrence Report” (AOR), from February 2025 - July 2025 revealed one fall incident every month for five of six months reviewed. The AOR revealed that on 7/25/25 P#1, “Tripped at the scale with (name of the Administrative Assistant - Staff AA) and (name of Patient Care Technician - PCT AA), next to patient (P#1). (Staff AA) assisted the patient (P#1) in stopping fall and reported that only the left knee hit the floor. The patient (P#1) stated knee hurt initially. (Name of RN AA) gave pt (P#1) an ice pack for her knee and notified (name of Medical Director - MD), of pt’s (P#1’s) fall. Pt (P#1) stated that her knee felt better during treatment and was able to extend lower leg multiple times during treatment. After treatment, patient (P#1) ambulated to scale without assistance from staff or a device and was discharged to lobby”. Additionally, the AOR showed the following incidents: - February 2025: P#2 had a fall incident in the facility’s parking lot - March 2025: P#2 had another fall incident in the facility’s parking lot - May 2025, P#3 had a fall incident at the entrance to the facility - June 2025, P#4 had a fall incidence at the Patients’ Lobby A review of the facility’s QAPI meeting minutes dated June 27, 2025, stated that the facility identified three patient safety events involving falls that occurred outside the facility since January 2025. Two of these incidents involved the same patient (P#2). However, there were no documented evidences of a root cause analysis, an action plan, or any patient and staff education related to these events. A review of the facility’s staff “Training Records” from July 2024 to July 2025 revealed a total of five in-service trainings. However, falls, prevention, precautions, and interventions were not covered, even though there had been a history of one patient fall incident per month for five months out of six months of AOR reviewed. During interviews on 7/30/25 between 9:28 a.m. and 3:42 p.m., the following was revealed: During a telephonic interview with P#1’s representative (family member) at 9:28 a.m., she stated that P#1 had fallen at the facility on 7/25/25 while weighing at the Patients’ Weighing Scale due to an uneven surface. She stated that P#1 was a transient patient at the facility and was 71 years old. She added that after returning home from the treatment, P#1 complained of a worsening knee pain (both knees), to the point where she was unable to walk to her own room. The family took P#1 to an Urgent Care Clinic the following day (7/26/25), where P#1 received care. P#1’s representative stated that the Radiologist communicated to the family over the phone that P#1 had fractured both of her knees. The x-ray results were not available at the time of this investigation. - At 1:32 p.m., RN BB stated he did not witness P#1’s fall on 7/25/25. He confirmed that he did only the post-treatment assessment for P#1, and “she was fine”. RN BB also confirmed that a wheelchair was not offered to P#1 (post dialysis treatment). - At 1:49 p.m., PCT AA, who was assigned as dialysis care giver to P#1 on 7/25/25, stated that RN AA let P#1 into the Patient Treatment Room while she (PCT AA), was in the bathroom. PCT AA also stated, she was washing her hands at the clean sink in the Patient Treatment Room when she witnessed P#1’s fall at the weighing scale with Staff AA next to P#1. PCT AA was not with Staff AA when P#1 fell (which did not corroborate the statement in the AOR). PCT AA added, “Staff AA tried to break the fall by grabbing P#1’s right elbow, but P#1 was already on her knees”. PCT AA confirmed that after the fall incident, P#1 walked to her assigned station (S8) from the weighing scale for her dialysis treatment (even after complaining of pain on her knee). After treatment, P#1 was not offered a wheelchair and walked from S8 to her daughter’s car at the parking lot, accompanied by PCT AA and P#1’s daughter. At 3:29 p.m., the Clinical Manager said that she was not present in the facility when the incident (P#1’s fall) occurred. She confirmed that no Progress Notes were made regarding P#1’s fall and acknowledged that the staff could have done better with documentation. During a telephonic interview with the Medical Director at 3:42 p.m., he said that he was informed of P#1’s fall on the same day the incident occurred, while P#1 was already undergoing dialysis treatment. The Medical Director also confirmed that he did not give an order for P#1 to get an X-ray of the affected area. According to the National Institute of Health (NIH), dialysis patients are at increased risk of bone fractures due to fragile bones. This condition develops because of impaired kidney function, which disrupts the body’s ability to regulate minerals like calcium and phosphorus, and hormones like parathyroid hormone (PTH - hormones that maintain the right balance of calcium in the blood and is crucial for nerve and muscle function). Additionally, NIH emphasized that age can further increase fracture risk in dialysis patients. A review of facility P & P with Reference #61085, titled, “Patient Safety Reporting and Documentation,” published on 2/6/23, stated: Purpose: Provide a standardized process for management of all patient related safety events. . . Promote a culture of patient safety. Definitions: “Safety Event” results in mild to moderate patient clinical harm, not due to an underlying disease or condition. Requires additional monitoring, intervention, and /or medical care. Documentation: - Clinical Staff will complete documentation in the Patient Medical Record, Patient Safety Data Entry Site . . . Review during Quality Assessment and Performance Improvement (QAPI). - Documentation of all patient events shall be: Factual, complete, timely and concise. Include patient assessment and represent an accurate recording of the events, times, interventions, and result of interventions. . . . Determine additional staff educational needs. Categories, Event Descriptions and Definitions Fall - an unplanned descent to the floor or ground. . . A review of facility P and P with Reference #45284, titled, “Patient Assessment and Monitoring”, published 5/1/23, version 4, stated: Pre-treatment: 1. The direct patient care staff may obtain the following data. General Observation: Record any changes in overall condition. Some examples include: Has the patient fallen since their last treatment? Reported by the patient: Ask the patient if he or she has any new complaints or has fallen since their last treatment. Record any new complaints or if the patient has fallen since last treatment. 2. Document findings and interventions in the medical record. A review of facility P & P with reference #45265, titled, “Nursing Supervision and Delegation,” published on 11/6/23, stated: Policy: The registered nurse must evaluate each patient. . . talk to the patient to elicit information such as changes in condition, response to treatment, new injuries, information/education needs or complaints, satisfaction with care. Record review: Identify any process that could have resulted in the patient experiencing a safety event or near miss. The record must be reviewed for: Reported fall. . . Documentation: Document all findings in the patient’s medical record. The Team Leader/ Charge Nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions are necessary: - All reports of a fall regardless of location. A review of facility P & P with reference #46940, titled, “Medical Record Documentation Standards,” published on 2/5/24, stated: Policy: The dialysis facility must monitor and maintain complete, accurate, and accessible records on all patients. Entries: . . . To summarize events that occurred over a period of time (such as shift), the notation should indicate the actual time the entry was made with the narrative documentation identifying the time events occurred if time is pertinent to the situation. Completeness: Document all facts and pertinent information related to an event, course of treatment, patient’s condition, response to care and any deviation from and reason for deviation of standard treatment. Content: - All treatment information, treatment related events, change in a patient’s condition or significant care issues must be noted and charted. Documentation must include evidence of follow-through. - When documenting an adverse event, document the facts of the occurrence in the progress notes. Do not document the safety event report had been completed or refer to the report in charting. - Describe signs and symptoms, use quotation marks to quote the patient and document the patient’s response to care.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 49321 Based on observation, a review of facility policies, and staff interviews, it was determined that the Infection Control Committee failed to ensure that all direct patient care staff cleaned and disinfected sharps containers after each patient treatment and immediately cleaned the blood off the treatment floor and disinfected the affected surface as soon as feasible. This breach in infection control could lead to transmission of bloodborne pathogens (such as hepatitis B virus) and other infections from one patient to another in hemodialysis units. The facility census was 67. Findings were: During observation in the Patient Treatment Room on 8/26/24 between 2:00 p.m. and 3:30 p.m, the following was revealed : - The sharps containers at Station (S) 5, S18, S19, and S20 were completely filled with fistula needles. - The sharps container at S10 had a bloody fistula needle that hanged out of the container. - There were three drops of blood on top of the plastic lid of the sharps container located at S6. - There were three drops of blood on top of the plastic lid of the sharps container located at S16. - There was blood about the size of a dime on the floor to the right of the patient scale. - The large trash can located between S7 and S8 had a drop of blood on the lid. A review of Policy Reference Number 47806 titled, “Cleaning and Disinfection of Dialysis Station” published 9/5/23 stated: - Use 1:100 bleach solution to clean surfaces with visible blood. - After cleaning up all visible blood, use a new cloth with 1:100 bleach solution for a second cleaning of the surface... - Clean and disinfect any surfaces contaminated with blood or other potentially infectious material immediately or as soon as feasible. A review of Policy Reference Number 47685 titled, “General Cleanliness and Infection Control Guidelines” published 2/7/22 stated: All containers for storage or disposal of needles/sharps shall be replaced when no more than 2/3 to 3/4 full... During an interview on 8/14/24 at 11:50 a.m., Registered Nurse (RN) AA acknowledged the blood on the floor to the right side of the scale and explained that yesterday (8/13/24), a patient started bleeding at the scale and the staff did not clean up all the blood. RN AA also acknowledged the blood on the trash can and said that staff was aware not to put bloody material in the regular trash can. During an interview with Patient Care Technician (PCT) AA on 8/14/24 at 2:30 p.m., she stated that PCTs were taught to wipe the sharps containers and if needed, change them at the end of each day but the staff who was responsible for her section today, did not wipe or change the sharps containers yesterday. The Director of Operations was notified of the above findings on 8/14/24 at 2:45 p.m. and stated that the clinical staff just had an inservice a few weeks ago on the above issues.”