Davita East Macon Dialysis Center

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of facility Policy and Procedures, 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 55 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross Reference: V 757 - Failure of the Facility Administrator to ensure the facility had adequate number of qualified staff to meet the needs of all patients as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 12 patients who were receiving dialysis care; and that each care giver was not assigned more than four patients each shift.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 52051 Based on observation, staff interviews, a review of the Food and Drug Administration (FDA) recommendations, and a review of facility Policies and Procedures (P&P), it was determined that the facility failed to ensure that two of two Licensed Nurses (Registered Nurse [RN] AA and Licensed Practical Nurse [LPN] AA), who were responsible for administering medications, discarded and not made available for use, expired medications in one of one Medication Refrigerator and one of one Emergency Cart in the hemodialysis Patient Treatment Room. This failure could render medications and supplies to be unsafe and ineffective, and had the potential to negatively affect the health and safety of all 55 in-center hemodialysis (ICHD) patients who were under the care of this facility. Findings include: - During a tour of the Patient Treatment Room with the Nurse Manager on 5/12/25 at 10:00 a.m., the following was revealed: In the Emergency Crash Cart: - One bag Normal Saline Solution (1000 milliLiter (mL)/bag), used in intravenous drips to treat dehydration, electrolyte imbalances, and used to replace extracellular fluids such as in cases of hemorrhage, sepsis, and hypovolemia, expired 10/2024. - The Nurse Manager, who accompanied this surveyor during the inspection of the crash cart, stated that it is the charge nurse’s (RN AA’s) responsibility to oversee this task. The Nurse Manager acknowledged this observation on 5/12/25, at 10:11 a.m. - During an interview with RN AA on 5/14/25 at 10:56 a.m., she confirmed that she checked the contents of the crash cart in each drawer once a week, typically on a Monday. She added that she may have overlooked the expiration date on the saline bags. During observation in the Patient Treatment Room on 5/12/25 between 10:15 a.m. and 12:00 p.m., the following was revealed: In the Medication Refrigerator: - There were five prefilled syringes of Mircera (used for the treatment of anemia), contained in their respective boxes and labeled expired. 1. Three syringes had a dosage of 200 mcg in 0.3 ml, expired 10/2024. 2. Two syringes had a dosage of 150 mcg in 0.3 ml, expired 8/2024. - During an interview with the Nurse Manager who was present at the time of observation, on 5/12/25 at 10:40 a.m., she acknowledged that expired medications should not be kept in the medication refrigerator at the nurses’ station. The Nurse Manager also stated that the Administrative Assistant (AA) is responsible for inventory management. - During an interview with the AA, on 5/12/2025 at 11:21 a.m., she confirmed that she was aware of the expired medications that were still being stored in the medication refrigerator. The AA also mentioned that she had labeled these medications as expired while waiting for the vendor to send the labels for the products that were to be returned. - On 5/13/25 at 8:39 a.m., the Facility Administrator was notified of the expired Mircera and she stated that expired medications should not be stored in the medication refrigerator. According to FDA recommendations dated 2/08/21, drug expiration dates indicate the timeframe during which the product is expected to remain stable. This means it retains its strength, quality, and purity when stored according to the specified conditions on the label. Utilizing expired medications or supplies can pose various potential risks. Once the expiration date has elapsed, there is no assurance that the medication or supplies will continue to be safe or effective. A review of the facility’s Policy: 1-06-01 titled, “Medication Policy” with the latest revision date of October 2023, showed the following: 30. All medications in the facility are checked monthly for expiration dates. 31. Medications are ordered and replaced prior to expiration. 32. Disposal of expired medications, including all over-the-counter and nutritional product samples, are removed from the treatment and inventory areas and disposed of per state/local regulations.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and a review of facility Policies and Procedures (P & P), it was determined that the Infection Control Committee failed to ensure that one of one Licensed Practical Nurse (LPN AA) and three of three Patient Care Technicians (PCT AA, PCT BB, and PCT CC) observed, performed hand hygiene (handwashing with soap and water or use of an alcohol-based hand sanitizer) after removing contaminated gloves, between glove changes, and after touching contaminated equipment. This breach in infection control techniques, such as hand hygiene, had the potential to increase the risk for cross contamination with the potential to expose patients and staff to bloodborne pathogens in the dialysis environment. The facility in-center census was 55. Findings include: During observation in the Patient Treatment Room on 5/12/25 between 10:30 a.m. and 12:00 p.m., the following was revealed: - LPN AA was observed adjusting a patient’s blood pressure (BP) cuff without wearing gloves, at Station (S) 23. Without performing hand hygiene, LPN AA reset the dialysis machine alarm at S20 using a glove that was in her hand, rather than wearing it properly. LPN AA then proceeded to S15, where she re-adjusted another patient’s BP cuff without wearing gloves and without performing hand hygiene between these patient stations. During an interview conducted on 05/12/25 at 10:45 a.m., LPN AA stated that she was unaware that she was not wearing gloves when handling the BP cuffs. - PCT BB was observed silencing the machine’s alarm at S9 using a glove that was in her hand, rather than wearing it properly. PCT BB did not perform hand hygiene before and after silencing the machine’s alarm. During an interview with PCT BB on 05/12/25 at 11:15 a.m., she stated that she was moving quickly and became distracted. - PCT CC was observed resetting the machine’s alarm at S4 while holding a glove in his hand, rather than wearing it properly. After discarding the used glove, PCT CC did not perform hand hygiene before putting on a new pair of gloves. PCT CC then went to S2 to adjust a patient’s BP cuff. After completing the task, PCT CC removed his gloves and without performing hand hygiene, PCT CC touched the computer keyboard (considered clean) to enter data. During an interview with PCT CC on 05/12/25 at 11:25 a.m., he stated that he is new to the role and was feeling very nervous at the time. - PCT AA was observed silencing the dialysis machine’s alarm at S20 using a glove that was in her hand, rather than wearing the glove properly. PCT AA did not perform hand hygiene before and after this task. PCT AA stated on 05/12/25 at 11:30 a.m., that she was not paying attention (not performing hand hygiene) at that time. After a brief power outage on 5/12/25, the following was observed: - PCT AA was observed resetting the dialysis machines at S13, S14, S15, and S16 without changing gloves and without performing hand hygiene between stations. - LPN AA was observed resetting the dialysis machines at S22, S21, and S17 without changing gloves and without performing hand hygiene between stations. - PCT CC was observed resetting the dialysis machines at S3, S4, S5, and S6 while holding a glove in his hand rather than wearing it properly. PCT CC did not change gloves and did not perform hand hygiene between stations. - On 05/12/25 at 1:00 p.m., the Registered Nurse/Clinical Coordinator acknowledged these findings. According to CDC recommendations, gloves are designed to act as a barrier, but the outer surface is often contaminated after patient care or contact with bodily fluids or surfaces. During glove removal, your bare hands may come into contact with these contaminants, even if you remove gloves carefully. Gloves are meant for single-task, single-patient use. Using the same gloves across different areas or patients - even with good intentions - spreads pathogens, especially if hands are not cleaned in between. A review of Policy #1-05-01 titled, “Infection Control for Dialysis Facilities”, with latest revision date of April 2023, stated: Hand Hygiene: 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact... g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse”

“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, staff interviews, a review of Centers for Disease Control and Prevention (CDC) guidelines, and a review of the facility’s Policies and Procedures (P & P), it was determined that the Infection Control Committee failed to ensure that three of three Patient Care Technicians (PCTs AA, BB, and CC) observed, who were assigned to these specific patient Stations (S), immediately and thoroughly cleaned and disinfected surfaces of sharps containers that were visibly contaminated with blood located between S1 and S2, S11 and S12, S13 and S14, as well as the sharps container in the Isolation Room (S24). This deficient practice increased the risk for transmission of bloodborne pathogens and other infections from one patient to another within the hemodialysis (HD) unit. The facility had 55 in-center Hemodialysis patients. Findings include: During observation in the Patient Treatment Room on 5/12/25 at 10: 40 a.m., the following was revealed: - The top of the sharps container between S1 and S2 had small dried drops of blood, as well as four drops of dried blood on the wall below the drain box behind S2. At the time of this observation, the machines and chairs of both stations had already been cleaned and disinfected after the patients left. - The sharps container between S11 and S12 had two moderate size drops of dried blood on the top plastic lid. A large amount of splattered blood was observed around the plastic openings of the sharps containers located between S13 and S14, as well as the sharps container inside the Isolation Room, (S24). During an interview on 5/12/25 at 10:44 a.m., PCT AA stated that sharps containers were wiped down at the end of the day. During an interview with PCT BB on 5/12/25 at 10:50 a.m., PCT BB stated that sharps containers were wiped down at the end of the day. During an interview with PCT CC on 5/12/25 at 10: 54 a.m., PCT CC stated that he was new at the facility. During an interview on 5/12/25 at 11:00 a.m. with the Nurse over Clinical Care, she stated that the staff knew that blood should be cleaned immediately. According to CDC guidelines, failure in environmental cleaning and disinfection has led to the transmission of bloodborne pathogens (e.g., Hepatitis B virus) and other infections from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including floor, sharps containers, patients’ chairs or bed surfaces, dialysis equipment surfaces, etc., especially with blood splatters) must be performed between patient use to prevent transmission of dangerous pathogens. -A review of facility Policy #1-05-01 titled, “Infection Control for Dialysis Facilities” revised April 2023, stated: DISINFECTION: 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the stations) and prior to returning to clean/designated area or removal from treatment area. iii. Cleaning of visible blood should be performed when first observed.”

“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 observation, staff interviews, and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that one of one Registered Nurse (RN) (RN AA), who prepared heparin injections (anticoagulant used in hemodialysis to prevent clotting in the bloodlines and dialyzer/artificial kidney) and oral medications for second shift patients, labeled six of six heparin syringes, and seven of seven oral medications in plastic medication cups, with date and time prepared, and her initials. This deficient practice increased the risk for medication errors. The facility had 55 in-center hemodialysis (ICHD) patients. Findings include: During observation in the Patient Treatment Room on 5/12/25 between 10:15 a.m. and 12:00 p.m., the following was revealed: In the Medication Preparation Area: - There were three 10 mL (milliLiters) syringes containing heparin injection for hourly infusion, three 5 mL syringes of heparin for bolus infusion, and seven medication cups with oral medications in them that were prepared and labeled with the patients’ names, but they lacked the staff’s initials and the date and time of preparation. - During an interview with the Nurse Manager who was present at the time of this observation, on 5/12/25 at 10:35 a.m., she acknowledged that medications were not labeled with date, time, and staff initials. The Nurse Manager also pointed out that it was RN AA (Charge Nurse), who had prepared them. - During an interview with RN AA on 5/12/25 at 10:59 a.m., RN AA confirmed that she prepared the heparin syringes and the oral medications for the second-shift patients. RN AA also stated that the oral medications in the medication cups, were to be administered to patients by both RN AA and Licensed Practical Nurse (LPN) AA. RN AA agreed that medications should be labeled with the date, time, and staff initials at the time of preparation. - During an interview with LPN AA on 5/14/25 at 8:37 a.m., she confirmed that RN AA prepared the oral medications for her (LPN AA’s) patients at Stations (S)13, S14, S15, S16, S17, S18, S19, S20, S21, S21, S22, S23, and S24 on 5/12/25. LPN AA also stated that typically, the charge nurse of the day prepared the medications. - A review of Policy #1-06-01 titled, “Medication Policy” dated October 2023, stated: 20. If medications are prepared and administered immediately by the same licensed nurse teammate, they do not need to be labeled. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient’s name, date, time prepared, dose, and initials of the teammate preparing the medication. - The facility P&P failed to include that all medications shall be administered by the individual who prepared them.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 49321 Based on a review of facility records, staff interviews, a review of facility Policy and Procedures (P & P), and a review of minimum state required staffing ratios, it was determined that the Facility Administrator failed to ensure the facility employed an adequate number of qualified staff to meet the needs of all patients as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge and deal with unexpected complications of dialysis, for every 12 patients receiving dialysis care and that each care giver was not assigned more than four patients at any given time. This deficient practice had the potential to cause a delay in monitoring patients for issues such as fluid overload (an excessive amount of fluid in the body), changes in vital signs, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, delayed adjustments, or missed complications including but not limited to: intradialytic hypotension (sudden drops in blood pressure which can occur when fluid is removed too rapidly), arrhythmias (irregular heartbeat), and other medical issues and emergencies related to hemodialysis. The facility in-center hemodialysis census was 55. Findings include: During a review of the facility’s Staff/Patient schedule between 5/5/25 and 5/12/25, the following was revealed: The facility had 24 patient stations, including one Isolation Room, organized into six Pods (each Pod with four patient stations [S]). Dialysis treatments were scheduled with two main rotations: Mondays-Wednesdays-Fridays (M-W-F) and Tuesdays-Thursdays-Saturdays (T-T-S), with two shifts per day. On the M-W-F schedule: First shift: 17 patients on Mondays and Fridays, and 16 patients on Wednesdays. Second shift: 16 patients on Mondays and Fridays, and 15 patients on Wednesdays. On the T-T-S schedule: First shift: 10 patients. Second shift: nine patients (except on Thursdays, when there were eight patients scheduled for dialysis). Staffing Schedule for 5/5/25 and 5/12/25 - First and Second Shifts: - PCT CC (new PCT), was assigned to four patients (first shift) and four patients (second shift) at Stations (S) 1, S2, S3, and S4. - PCT BB was assigned to four patients (first shift) and six patients (second shift), at S5, S6, S9, S10, S11, and S12. - PCT AA was assigned to six patients (first shift) at S13, S14, S15, S16, S17 and S24 (Isolation Room) during first shift and four patients (second shift). - Licensed Practical Nurse (LPN AA) was assigned as a direct caregiver to three patients during the first shift at S20, S21, and S22. In addition, LPN AA was responsible for nursing duties to six other patients, including administering medications, performing pre and post treatment assessments, handling phone calls, and setting up and breaking down dialysis machines. During the second shift, LPN AA was assigned as a direct caregiver to two patients and was responsible for nursing duties to three additional patients. - The schedule for 5/7/25 (Wednesday), showed the following: - PCT DD (new PCT) was assigned to four patients (first shift) and four patients (second shift). - PCT BB was assigned to four patients (first shift); six patients (second shift) - PCT AA was assigned to five patients (first shift); four patients (second shift). - LPN AA was assigned as direct caregiver to three patients on first and second shifts, in addition to her nursing duties. Staffing Schedule for 5/6/25 - First and Second Shifts: - PCT EE (Float PCT) was assigned to four patients (per first and second shift). - PCT BB had four patients (per first and second shift). - PCT AA had five patients (first shift) and four patients (second shift). - RN BB was the only licensed nurse and was responsible for 13 patients on first shift. During an interview conducted on 5/14/25 at 08:37 a.m., LPN AA reported the following: She was consistently responsible for conducting assessments and administering medications for all patients scheduled in Pods 4 through 6, including the Isolation Room. She stated that she worked closely with PCT AA, as both are assigned on the same side of the treatment room (Pods 4 through 6 including the Isolation Room). LPN AA also added that the workload can be overwhelming at times, due to the combined responsibilities as a direct patient caregiver and nursing duties. During an interview conducted on 5/14/25 at 08:56 a.m., RN AA provided the following information: RN AA stated that although she served as the Charge Nurse, she was also responsible for the care of Patient (P), (P#10), who had a Central Venous Catheter (CVC) at S6 during the second shift on M-W-F. RN AA clarified that PCTs cannot initiate treatment for patients with CVC, though they are permitted to perform the 30-minute checks. Additionally, PCTs are not allowed to perform rinse-back procedures on patients with CVC. Another patient at S5 on second shift (M-W-F) was assigned to a PCT, which resulted in that PCT to have a total of five patients during the shift. RN AA acknowledged that the workload can be overwhelming at times, as her responsibilities include preparing medications, conducting patient assessments, assisting with rinse-back during turnover, and making clinical decisions when a patient became ill. During an interview conducted on 5/14/25 at 9:15 a.m., the Clinical Coordinator stated: LPN AA was responsible for the care of patients located at Stations 22, 21, and 19. In addition, LPN AA was also responsible for conducting pre and post treatment assessments, administering medications, and providing overall care for patients at S13, S14, S15, S16, S17, and S24 (Isolation Room). The Clinical Coordinator also confirmed that the Charge Nurse was required to take a patient during the second shift, and that the PCT assigned to Pod 3 was responsible for five patients on M-W-F scheduleduring the second shift. During an interview conducted on 5/14/25 at 10:21 a.m., PCT AA stated: She was responsible for Stations 13 through 17, as well as S24 (Isolation Room). She stated that the workload can be overwhelming at times, but added that she and LPN AA worked well together and provide mutual support. PCT AA explained that they were typically assigned to the same area, which helped with coordination and patient care and when a staff member was absent, a float PCT was assigned to cover the absent PCT’s Pod. She also added that patients may occasionally require an additional dialysis treatment on an unscheduled day and that can add to the number of patients assigned to a direct caregiver, which can increase the stress level of the staff. During an interview conducted on 5/14/2025 at 11:22 a.m., PCT BB stated: Her assigned stations were S9, S10, S11, and S12. However, she also took care of patients at S5 and S6, since PCT CC was new and the nurse on that side of the treatment room had a high workload. PCT BB expressed concern about overwhelming the new PCT. She stated that she wanted to support PCT CC to help ensure he was not discouraged and decide to quit. PCT BB added that the schedule can be especially overwhelming during turnover (shift change), when patients transitioned and tasks peaked. On 5/14/2025 at 11: 30 a.m., the Facility Administrator acknowledged the above findings. A review of Policy #8-02-01, titled, “Teammate Qualifications, Licensure and Adequate Teammate Staffing”, last revised October 2017, stated: POLICY: 4. An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care giving and meets the need of the patients.”