Colquitt Regional Medical Center Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, a review of facility records, a review of the manufacturer’s Directions for Use (DFU) for Total Chlorine testing (to detect the presence of chlorine in water for dialysis), a review of the facility’s Policies and Procedures (P&P), and a review of the Reverse Osmosis (RO) System Operation Manual, it was determined that the facility failed to ensure that two of two Registered Nurses (RN AA and RN BB) and one of one Patient Care Technician (PCT AA) assigned to test water quality, performed Total Chlorine Test according to the manufacturer’s DFU, the facility’s P&P, and the guidance outlined in the RO System Operation Manual. Failure to accurately perform Total Chlorine Test posed a serious patient safety risk. Residual Total Chlorine in dialysis water can cause hemolysis (destruction of red blood cells). The facility census was 85. Findings include: Cross Reference: V196 - Failure of the facility to ensure Direct Patient Care (DPC) Staff (RN AA, RN BB, and PCT AA) who were assigned to test the water quality, performed the Total Chlorine Testing according to the manufacturer’s DFU, used the correct test strips and documented the exact time testing was performed.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, a review of facility records, a review of the manufacturer’s Directions for Use (DFU) and a review of facility Policies and Procedures (P & P), 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 85 in-center hemodialysis patients who dialyzed at this facility. Findings include: Cross Reference: V196 - Failure of the facility to ensure Direct Patient Care (DPC) Staff (Registered Nurses - RN AA, RN BB, and Patient Care Technician - PCT AA), who were assigned to test the water quality, performed the Total Chlorine Testing according to the manufacturer’s DFU, used the correct test strips and documented the exact time testing was performed.”

“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) recommendations and guidelines, and a review of facility Policies and Procedures (P&P), it was determined that the Infection Control Committee failed to ensure that two of two patients, (Ps) (P#7 and P#8) observed, who held pressure to their access sites for hemostasis (stopping of the flow of blood) after hemodialysis, were educated or reminded by three of three Patient Care Technicians (PCTs) (PCT AA, PCT BB, and PCT CC) observed, to perform hand hygiene (either by using a hand sanitizer or by washing with soap and water), after glove removal and prior to leaving the Patient Treatment Room. Failure to perform hand hygiene increased the risk of cross-contamination and had the potential to expose all patients and staff to bloodborne pathogens within the dialysis environment. The facility census was 85. Findings include: During observation in the Patient Treatment Room on 7/22/25 between 12:30 p.m. and 12:45 p.m., the following was revealed: - P#7 who was seated at Station (S) 6, held his dialysis access site with a gloved hand. After hemostasis was achieved, PCT AA removed P#7’s contaminated glove (without offering a hand sanitizer to P#7). P#7 was then transferred to a wheelchair and transported to the weighing scale by PCT CC. P#7 touched the button of the weighing scale to display his weight, and was subsequently pushed to the lobby by PCT CC. P#7 also touched the door knob before exiting to the lobby. PCT CC did not encourage or remind P#7 to perform hand hygiene, either by using a hand sanitizer or by washing his hands with soap and water. - During an interview with PCT AA on 7/22/25 at 12:35 p.m., PCT AA stated that the patients usually knew to wash their hands when they arrive and before they leave. - During an interview on 7/22/25 at 12:38 p.m., PCT CC stated she gave P#7 some hand sanitizer when he got in the lobby. - At 12:40 p.m., P#8, who was seated at S24, held his dialysis access site with a gloved hand. Once hemostasis was achieved, the contaminated glove was removed by PCT BB. P#8 was transferred to a wheelchair and was taken to the weighing scale. The same breach in infection control was observed. P#8 touched the button of the weighing scale to obtain his weight, then he was pushed to the lobby by PCT BB . P#8 was not encouraged or reminded by PCT BB to perform hand hygiene. - Additionally, the weighing scale button and the door knob were not disinfected by the PCTs after use or after P#7 and P#8 touched them. During an interview with PCT BB on 7/22/25 at 12:45 p.m., PCT BB acknowledged the finding but made no comment. On 7/22/25 at 2:00 p.m., the Facility Director was informed of the above findings. She stated that the staff (nurse and patient care technicians) were aware to encourage hand washing. According to CDC recommendations, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal ... A review of facility Policy #18026876, titled, “Dialysis Infection Control and Prevention”, revised 4/2025, stated: 19. Patients are to wear a glove when holding pressure on needle puncture sites and wash their hands IMMEDIATELY after leaving their treatment stations.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of the facility’s Policy and Procedure (P & P), it was determined that the Infection Control Committee failed to ensure that two of two Patient Care Technicians (PCTs), (PCT AA and PCT BB) observed, removed their personal protective equipment (PPE) such as gowns and goggles, prior to leaving the Patient Treatment Room (dirty area) and before going to a clean area, (Dialysate Preparation Room and Supply Room). Failure to remove contaminated gown worn at a dirty area before going to a clean area, had the potential for cross contamination. This deficient practice had the potential to negatively affect the health and safety of nine of nine patients (Ps) (P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, and P#16), who were undergoing hemodialysis at the time of this observation. The facility census was 85. Findings include: - During observation in the Patient Treatment Room on 7/22/25 10:30 a.m., PCT AA went to the Supply Room (clean area), wearing the same gown she wore in the Patient Treatment Room (dirty area). - During an interview on 7/22/25 at 10:35 a.m., PCT AA stated no one ever told them they had to remove their gown to go to the supply room. - During observation on 7/23/25 at 1:00 p.m., PCT BB was coming out of the Dialysate Preparation Room (clean area) wearing the same gown and goggles she was wearing while in the Patient Treatment Room. - During an interview on 7/23/25 at 1:15 p.m., PCT BB stated that no one ever said it was an issue coming off the Patient Treatment Room with the same gown and goggles on. - On 7/23/25 at 2:00 p.m., the Facility Director was notified of the above findings. A Review of facility Policy #16139803, titled, “Standard Precautions, Dialysis Task and Personal Protective Equipment”, revised 6/2020, stated: Special Instructions: 2. All PPE must be removed before leaving the treatment floor.”

“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) recommendations, and a review of the facility’s Policies and Procedures (P&P), it was determined that the Infection Control Committee failed to ensure that all Direct Patient Care (DPC) Staff (nurses and patient care technicians), promptly and thoroughly cleaned and disinfected blood-contaminated surfaces and dialysis equipment when first observed and after patients completed their hemodialysis treatments. This deficient practice increased the risk for cross-contamination and transmission of dangerous pathogens, potentially affecting negatively, the health and safety of all 85 in-center hemodialysis patients who were under the care of this facility. Findings include: On 7/22/25 at 1:30 p.m., during a tour of the Patient Treatment Room with the Charge Nurse (Registered Nurse - RN AA), after all patients had left the facility, the following was observed: Dried drops of blood were found on the lids of five large sharps containers at: - In front of Station (S) 2: one medium-sized dried drop of blood. - In front of S13: three small dried drops of blood. - On the side of S15: two dried drops of blood. - In front of S18: five dried drops of blood. - In front of S20: one dried drop of blood. - The hemodialysis machines at S1, S2, S3, S7, S13, S14, S19, S22, S23, and S24 had visible thick white buildup. The residue was located on the right side of the Baxter dialysis machines, specifically near the clear cartridge and around the acid and bicarbonate ports at the front of the machines. During an interview with RN AA on 7/22/25 at 1:33 p.m., RN AA stated that sharps containers were wiped down once a week. When asked about the white substance observed on the dialysis machines, RN AA stated that it was residue left from cleaning the machines with bleach. At 2:00 p.m., on 7/22/25, the Facility Director was informed of the above findings. The Director stated that sharps containers should be wiped down whenever blood is visible. She also confirmed that the white buildup on the dialysis machines were residue from the bleach cleaning solution. According to CDC guidelines, failure in environmental cleaning and disinfection have led to 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 floors, patient chair or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces, etc., especially with blood splatters) must be performed between patient uses to prevent transmission of dangerous pathogens. A review of facility Policy #18026876, titled, “Dialysis Infection Control and Prevention”, revised 4/2025, stated: 8. Each dialysis stations will be cleaned and disinfected between patients. Chairs, machines, and containers for disposal will be cleaned and disinfected with a 1:100 germicidal bleach. 9. Blood spills will be immediately cleaned with a cloth soaked with a 1:100 bleach solution.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 49321 Based on a review of medical records, staff interviews, a review of facility Policy and Procedure (P & P), and a review of the Centers for Disease and Control Prevention (CDC) recommendations, it was determined that the Infection Control Committee failed to offer Hepatitis B vaccination to three of six patients Ps) (P#4, P#5, and P#6) sampled, who were susceptible to Hepatitis B virus (HBV) infection, as evidenced by Hepatitis B surface antibody (anti-HBs) levels below 10 mIU/mL (milli-international units per milliLiter). Hepatitis B is a highly infectious disease of the liver transmitted through blood and other body fluids. This deficient practice had the potential for risk of exposure to HBV (in a high-risk dialysis setting) of P#4, P#5, and P#6. The facility census was 85. Findings include: During a review of facility records the following was revealed: - P#4 Hepatitis B surface antibody was 7.2 - P#5 Hepatitis B surface antibody was 2.1 - P#6 Hepatitis B surface antibody was 5.1 - During an interview with the Facility Director on 7/24/25 at 6:30 a.m., she stated that patients were referred to the Health Department for Hepatitis B vaccination. The facility did not offer Hepatitis B Vaccinations. There was no documentary evidence if P#4, P#5 and P#6 were offered Hepatitis Vaccination or their declination. A review of facility Policy #18028283, titled, “Management of Infected Patients”, last revised 4/2025, stated: - All patients of CRMC Dialysis Services (referring to this facility) are encouraged to consent to receiving the Hepatits B Vaccine. It is AVAILABLE at this facility. According to CDC guidelines, patients with Hepatitis B surface antibody (anti-HBs) levels below 10 mIU/mL, particularly those receiving hemodialysis, should be revaccinated to ensure continued protection against Hepatitis B virus. The CDC recommends administering a booster dose or a repeat vaccine series using high-dose formulations such as Engerix-B (40 µg) or Recombivax HB (40 µg), following a 3- or 4-dose schedule. For dialysis patients, anti-HBs titers should be monitored annually, and revaccination should occur whenever levels fall below the protective threshold of 10 mIU/mL. Patients must be offered the vaccine and given the opportunity to accept or decline, with documentation maintained in the medical record. This is critical in high-risk dialysis settings, where patients are more vulnerable to bloodborne infections and the consequences of inadequate immunization can be severe.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, a review of facility records, a review of the manufacturer’s Directions for Use (DFU) for Total Chlorine testing (to detect the presence of chlorine in water for dialysis), a review of the facility’s Policies and Procedures (P&P), and a review of the Reverse Osmosis (RO) System Operation Manual, it was determined that the facility failed to ensure that two of two Registered Nurses (RN AA and RN BB) and one of one Patient Care Technician (PCT AA) assigned to test water quality, performed Total Chlorine Test according to the manufacturer’s DFU, the facility’s P&P, and the guidance outlined in the RO System Operation Manual. Failure to accurately perform Total Chlorine Test posed a serious patient safety risk. Residual Total Chlorine in dialysis water can cause hemolysis (destruction of red blood cells). The facility census was 85. Findings include: - On 7/22/25 at 1:05 p.m., RN AA was observed performing Total Chlorine testing at the facility’s water sample box. RN AA obtained 30 mL (milliLiter) of water sample from the softener/chlorine testing sample port. RN AA did not flush the sample port for one minute prior to the sample collection. RN AA proceeded to use the Serim Guardian Residual Chlorine test strip (used to provide a convenient means for indicating the concentration of chlorine bleach [sodium hypochlorite] remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment), by moving the strip back and forth in the sample for 30 seconds and reading the results within 10 seconds. Next, she then used a WaterCheck 2 strip by placing it directly under the faucet, turning on the faucet, and holding the strip in the running water for 30 seconds (the port was not flushed for one minute). She compared the strip to the color chart on the bottle and recorded the result. When asked why two different water tests were conducted, RN AA stated that she had been trained to perform both tests as part of the chlorine testing process. It was further noted that although the testing was completed at 1:15 p.m. on 7/22/25, RN AA documented the time of testing as 1:00 p.m. - On July 22, 2025, at 2:00 p.m., the Facility Director was made aware of the above findings. On July 24, 2025, at 4:20 a.m., the following was revealed: - RN BB and PCT AA were asked by this surveyor, who performed the first Total Chlorine test. PCT AA responded that she had already completed the first Total Chlorine test on this date (7/24/25) and PCT AA added that this surveyor could watch her perform the 9:00 a.m. Total Chlorine test if desired. This surveyor reviewed the water log, which indicated that the Total Chlorine test had been documented as completed at 4:58 a.m., on 7/24/25. This surveyor asked why, if the test had been completed before 4:20 a.m. (surveyer time of arrival), it had been recorded as occurring at 4:58 a.m. No response was given. - RN BB stated on 7/24/25 at 4:22 a.m., that she and PCT AA would repeat the Total Chlorine test using the Serim Guardian Residual Chlorine method. PCT AA filled a 30 mL cup with 20 mL of water sample. PCT AA did not discard the first sample prior to testing. PCT AA immersed the test strip, then moved it back and forth for 30 seconds, and compared it to the reference chart within 10 seconds. This surveyor asked both RN BB and PCT AA if another test should be performed along with this one. Both RN BB and PCT AA stated that no additional Total Chlorine test was needed. - The Facility Director was notified of the above findings on July 24, 2024, at 5:15 a.m. WaterCheck 2 testing was completed before patients began dialysis. - A review of the facility’s, “Daily Water Treatment and Solutions Log”, from May 19, 2025, to July 5, 2025, revealed that the times 5:00 a.m., 9:00 a.m., 1:00 p.m., and 5:00 p.m., were pre-printed in boxes on the log. Staff documented test results and their initials in the corresponding sections. However, for the reviewed months (mentioned above), only one test result was documented per actual time, with no indication of whether the Serim Guardian Residual Chlorine Strips or the WaterCheck 2 Strips were used. - A review of the manufacturer’s DFU of the Serim Guardian Residual Chlorine Test Strips, stated: WARNING AND PRECAUTIONS Do not use SERIM GUARDIAN RESIDUAL CHLORINE Test Strips to measure low levels of chloramine in treated water. These test strips are not sensitive enough to meet the AAMI standard of 0.1 ppm chloramine for treated water used in making dialysate. Semi-Quantitative Method: 1. Using a clean container, fill the container with sample. Discard contents and re-fill (20 mL of sample required). - A review of the manufacturer’s DFU of the WaterCheck 2 Test Strips, stated: DIRECTIONS FOR USE: ... 0.1 ppm (parts per million) Chlorine/Chloramine Test: 1. Turn on the test water to a slow running stream and let the water run for about 1 minute to flush out the piping system. 2. Remove a WaterCheck 2 chlorine/chloramine test strip from the bottle and replace the cap tightly immediately. 3. Hold the strip under the water stream for 30 seconds. 4. Compare the strip color with the color blocks on the label. 5. If the strip color falls between two color blocks, interpolate the results. - A review of facility Policy #16150256, titled “Chlorine/Chloramine Testing”, last revised 6/2020, stated: Dialysis personnel will test and record the chlorine reading prior to each shift, NOT TO EXCEED FOUR HOURS. Note: All TESTS AND CHLORINE READINGS should occur after both RO 1 and RO 2 are placed in manual feed for 15 minutes. A. 1. Remove a strip from the bottle and immediately replace the cap tightly. 2. Turn on the sample port between the first and second carbon tank for 30 seconds to flush the tube. 3. Adjust the flow to slow running water. 4. Hold the strip with the reagent pad facing up under the water for 30 seconds. 5. Immediately compare the strip color with the color blocks on the label. B. 1. Collect at least 20 mL of test water in a 100 mL beaker or a container of at least two inches in diameter. 2. Dip a test strip in the test water, and move the strip back and forth moderately (2 strokes/second) for 30 seconds. 3. Compare the strip color with the color blocks. If a darker edge develops around the reagent pad, particularly at high chlorine levels, use the center part of the pad for comparison. - A review of the AmeriWater Reverse Osmosis System Operation Manual, page 19, stated: 7. It is important to test for chlorine and chloramines at the CHLORAMINE SAMPLE PORT every four hours when using the system. Chlorine will deteriorate the membrane and cause system failure. It is recommended to use a Total Chlorine test kit, such as WaterCheck 2 Low-Level Chlorine/Chloramines Test Strips.”