Spalding County Dialysis

“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: 50244 Based on observation, staff interview, and a review of facility Policy and Procedures (P& P), it was determined that the Infection Control Committee failed to ensure that eight of eight patients (P), (P#2, P#13, P#16, P#19, P#20, P#21, P#22, and P#27) observed, performed hand hygiene (washed hands or used an alcohol-based hand sanitizer), before hemodialysis treatment and after removal of contaminated gloves after holding their access sites when hemostasis (stopping of the flow of blood) was attained; and six of six patients (P#2, P#13, P#16, P#21, P#22, and P#27) observed, failed to wash their access sites prior to the initiation of their hemodialysis treatment. Failure to perform infection control techniques such as hand hygiene, increased the risk for cross contamination with the potential to expose other patients and Direct Patient Care (DPC) Staff to blood-borne pathogens in the dialysis environment. This deficient practice had the potential to negatively affect all 57 in-center hemodialysis patients who dialyzed at this facility and all 14 DPC Staff, (Nurses and Patient Care Technicians). Findings include: During observation in the Patient Treatment Room on 3/4/2024 between 8:00 a. m. and 8:30 a. m. and between 10:30 a. m. and 12:30 p. m., the following was revealed: - After each patient’s (P#2, P#13, P#16, P#21, P#22, and P#27) hemodialysis treatment was completed and their fistula needles were removed from the cannulation (needle insertion sites), these patients applied pressure to their access sites until hemostasis was attained. These patients removed their glove from their hand and exited the treatment room without performing hand hygiene. The DPC Staff did not remind them to perform hand hygiene. Prior to their hemodialysis treatment, P#2, P#13, P#16, P#19, P#20, P#21, P#22, and P#27, were observed entering the facility, weighing at the scale and going directly to their assigned hemodialysis station without performing hand hygiene. In addition, neither the patients nor the DPC Staff washed these patients’ vascular access. These findings were discussed with the Nurse Manager and the Facility Administrator on 3/4/2024 at approximately 1:00 p. m. The Facility Administrator stated that she would provide an inservice on infection control and patient vascular access care on that date. - A review of facility Policy titled, “ General Infection Control Practices” stated, “Patients wear a glove when holding sites after treatment. Patients wash their access before treatment and wash their hands before leaving the treatment area”.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 50244 Based on observation, staff interview, and a review of facility Policy, it was determined that the Infection Control Committee failed to ensure that five of five Direct Patient Care Staff (DPC AA, DPC BB, DPC CC, DPC DD, and DPC EE) observed, practiced infection control techniques to prevent cross-contamination. This deficient practice had the potential to negatively affect the health and safety of all 57 in-center hemodialysis patients who were under the care of this facility. Findings include: During observation in the Patient Treatment Room on 3/4/2024 between 10:00 a. m. and 12:30 p.m., the following was revealed: - The clean supplies used for the purpose of preparing the dialysis station for dialysis treatment were placed into white plastic bins (clean). DPCs AA, BB, CC, DD, and EE placed these clean supply bins on top or bottom of dialysis machines (dirty), and chairs (dirty) at the patients’ Stations (S), (S1 - S4, S6 -S19). The clean supply bins were not disinfected before returning them to the common area or clean counters. - Clipboards located on top of the dialysis machines were not disinfected between patient use. Items taken to a patient’s dialysis station could become contaminated with blood and other body fluids which had the potential for cross contamination. - A review of the facility’s Policy, titled, “General Infection Control Practices”, stated: “Practice Policy: Non-disposable items are disinfected between patient use: “ These findings were discussed with the Nurse Manager on 3/4/2024 at approximately 1:00 p. m.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 50244 Based on observation, a review of Centers for Disease Control and Prevention (CDC) Recommendations, and staff interview, it was determined that the Infection Control Committee failed to ensure that five of five common clean supply carts (used to store clean supplies in the patient treatment area), were kept in a designated area and not taken to the patients’ Hemodialysis Stations (S), (S1- S4, and S6 - S20), by five of five Direct Patient Care Staff (DPCs AA, BB, CC, DD, and EE) observed, to avoid cross contamination. This deficient practice had the potential to negatively affect the health and safety of all 18 patients (P), (P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22, P#23, P#24, and P#25), who were undergoing HD treatment at the time of this observation. The facility in-center patient census was 57. Findings include: During observation in the Patient Treatment Room on 3/4/2024 between 10:00 a. m. and 12:30 p. m., all five clean supply carts were not maintained in a designated area. All five DPCs (AA, BB, CC, DD and EE) observed, moved the clean supply carts between patients at stations (S1 - S4 and S6 - S20) to obtain needed supplies for pre-dialysis, during dialysis and post-dialysis patient care. According to CDC, if a common supply cart is used, it must be kept in a designated area away from any areas where the spurting or splattering of blood or fluid may occur. These findings were discussed with the Nurse Manager at approximately 1:00 p. m. on 3/4/2024. The Nurse Manager stated that she thought that the carts could be moved if the distance between the supply carts and patient stations were maintained at a five-foot distance”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 50244 Based on a review of personnel records, it was determined that the facility failed to ensure that one of one License Practical Nurse (LPN II), received infection control training initially on employment and at least annually thereafter. This failure had the potential to negatively affect the health and safety of LPN II and the 57 in-center hemodialysis patients who were under the care of this facility. Findings include: - A review of personnel records revealed that LPN II’s latest training on infection control and prevention was dated 9/14/2022. - This finding was discussed with the Nurse Manager and Facility Administrator on 3/6/24 at 4:00 p.m. Both Nurse Manager and Facility Administrator acknowledged this finding and were not able to provide a more current documentary evidence of LPN II’s infection control and prevention training.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 50244 Based on observation, a review of facility policies and procedures (P & P), a review of the Centers for Disease Control and Prevention (CDC) recommendations, and staff interview, it was determined that the infection control committee failed to ensure that two of two Registered Nurses (RN AA and RN BB), and one of one Licensed Practical Nurse (LPN FF) observed, used aseptic medication preparation techniques to prevent cross contamination in the treatment area. This breach in infection control techniques could negatively affect the health and safety of all 57 in-center hemodialysis patients who were under the care of this facility. Findings include: On 3/4/2024 at 8:40 a. m., RN AA was observed opening two single dose vials for injection. RN AA did not use alcohol pads to clean the vial stopper (or vial septum) prior to puncturing them with the needles. On 3/4/2024 at 8:48 a m., RN BB was observed drawing Heparin (anticoagulant) from a multi-dose vial. RN BB did not use alcohol pads to clean the vial stopper after opening the vial, nor prior to three re-entries into the same vial to draw up the Heparin medication. On 3/5/2024 at 8:50 a. m., LPN FF did not use alcohol pads to clean the vial stopper prior to withdrawing two separate doses of medication from the multi-dose vial. - A review of the Centers for Disease Control and Prevention (CDC) recommendations regarding Safe Injection Practices stated: Prepare injections using aseptic technique in a clean area. Disinfect the rubber septum on a medication vial with alcohol before piercing. - A review of the facility’s policy, titled, “General Infection Control Practices”, stated: “Ports of multi-dose vials will be wiped with alcohol prior to entry by a needle”. These findings were discussed with the Nurse Manager on 3/5/2024 at approximately 10:00 a. m.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 50244 Based on a review of personnel records, it was determined that the facility failed to conduct an Annual Water, Dialysate and Machine Competency Skills checks and periodic audits to one of one Licensed Practical Nurse (LPN II) who was assigned the task of testing/validating the water quality. This deficient practice had the potential to negatively affect the health and safety of 57 in-center hemodialysis patients who were under the care of this facility. Findings include: - A review of LPN II’s Personnel record revealed that LPN II’s latest Annual Water, Dialysate and Machine Competency Skills checks and periodic audits was dated on 1/31/2023. This finding was acknowledged by the Nurse Manager and Facility Administrator on 3/6/24 at 4:00 p. m. Both Nurse Manager and Facility Administrator were not able to provide a documentary evidence of LPN II’s Annual Water, Dialysate and Machine Competency Skills checks and periodic audits since 1/31/23.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 50244 Based on observation and staff interview it was determined that the facility failed to provide a method for patients to summon immediate/emergency assistance, from two of two Patient Bathrooms (BR), (BR#1- in the waiting area and BR#2 - inside the Treatment Room). This deficient practice had the potential to negatively affect the health and safety of 57 in-center hemodialysis patients who were receiving hemodialysis at this facility. Findings include: During a tour of the facility with the Nurse Manager on 3/4/2024 at 8:30 a. m., it was observed that the facility lacked a functional method for patients to call for help from Patient Bathrooms, (BR #1 and BR#2). The call lights from both bathrooms produced a barely audible sound in the Dialysis Treatment area. On 3/6/2024 at 1:00 p. m., facility staff attempted to increase the volume of the alarm but without success. The alarm sound was still barely audible. The Facility Administrator confirmed these findings on 3/4/24 at 8:35 a. m. and on 3/6/24 at 1:05 p. m. and she stated that she will have both bathroom call lights fixed.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 50244 Based on a review of the Quarterly Update of the Fiscal Year 2024 Dialysis Facility Report (DFR: A report prepared by the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients), a review of facility records, and staff interview, it was determined that the Quality Assessment and Performance Improvement (QAPI) Committee failed to track, trend, analyze, and develop plans of action for the facility’s In-Center and Peritoneal Dialysis (PD) Adequacy, PD Nutrition (Albumin - serum protein), and Transplant for six of six months (July 2023 - December 2023) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of 57 in-center hemodialysis patients and 16 PD patients, who were under the care of this facility. Findings include: A review of the Quarterly Update of the Fiscal Year 2024 DFR revealed the following: - The facility was above the United States (US) Threshold in: 1. Adequacy (Kt/V - measurement of the efficacy of a hemodialysis and peritoneal dialysis treatments) In-Center Kt/V less than (<) 1.2 was 8.4 % (Quarter 3 in QDFR). The US Threshold was 1.9 % PD Kt/V < 1.7 was 10.8 % (Quarter 3 in QDFR). The US Threshold was 5.3 %. 2. PD Nutrition - The Serum Albumin for PD (Q3 in QDFR) was 56.8 %, whereas the US Threshold was 50.5 %. - The facility was below the US Threshold for Transplantation: The % of Patients on the Active list was 2.5 %, whereas the US Threshold was 17 %. In comparison, a review of the facility’s last six months of QAPI meeting minutes from July 2023 - December 2023, revealed the following outcomes that were greater than (>) the US threshold. ICHD patients: 1. Kt/V less than (<) 1.2 for ICHD ranged from 6.0 % - 11 %. Although it improved to 6 % in November 2023, it was not sustained, it went up to 11 % in December 2023. The US threshold was 1.9%. 2. There was no record of the PD Kt/V <1.7 in the July 2023 - December 2023 QAPI Meeting minutes reviewed. During an interview with the PD Nurse Manager on 3/6/24 at approximately 3:30 p.m., the PD Nurse Manager acknowledged that the QAPI meeting minutes failed to identify specific analysis and action plans related to Kt/V <1.7 %.”

“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: 50244 Based on observation, staff interviews, and a review of facility Policy and Procedure (P & P), it was determined that the Medical Director failed to ensure that all Direct Patient Care (DPC) Staff - (Nurses and Patient Care Technicians), adhered to the facility’s P & P relative to patients’ access sites to remain uncovered during their hemodialysis treatment. This failure had the potential to negatively affect the health and safety of all 57 hemodialysis patients who dialyzed at this facility. Findings include: During observation in the Patient Treatment Room on 3/4/2024 at 8:10 a. m., it was revealed the access sites of patients (P), (P#1, P#2, P#3, P#4, P#5, P#6), were covered with a blanket. - The Nurse Manager was notified of the patients’ covered access sites on 3/4/2024 at 8:15 a.m.. and she proceeded to remove the blankets that covered the patients’ vascular access sites. During observation on 3/6/2024 at 10:00 a. m., it was revealed that the access sites of P#16 and P#17 were covered with blankets. - Registered Nurse (RN LL), was notified of these patients’ covered access sites on 3/6/24 at 10:03 a.m., and she removed the blankets that covered P#16’s and P#17’s access sites. - Allowing patients to cover their access sites and bloodline connections during hemodialysis treatment had the potential for accidental needle dislodgement or a line disconnection that could result in exsanguination and death within minutes. - A review of the facility’s policy, titled, “Permanent Access Care for the Hemodialysis Patient”, stated: “After initiation of treatment the access is to remain uncovered during the hemodialysis treatment. This will allow the nursing staff to monitor access at all times to ensure there is no bleeding at access site. This is to be noted on the treatment flow sheet every 30 minutes... Teach the patient the following information about access care...”