Fmc Conway Dialysis Center

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 30011 Based on observations, interview, and review of facility policy and procedure, the dialysis facility staff failed to ensure that clean supplies had been kept separated from possible contamination at handwashing sinks. The findings included: Observations on 4/15/24 at 2:20 PM to 3:00 PM of the dialysis treatment room floor revealed a covered container labeled as 1:100 (one to one hundred) bleach solution with clean bleach cloths noted inside, and a blue container with numerous dialysis clamps located next to sinks used for handwashing. Observation further revealed difficulty to access the clean paper towels for drying hands post handwashing due to the bleach container obstructing the paper towel dispenser. Observations on 4/16/24 at 8:10 AM to 11:55 AM of the dialysis treatment room floor revealed a covered container labeled as 1:100 bleach solution with clean bleach cloths noted inside and a blue container with numerous dialysis clamps located next to sinks used for handwashing. Observation further revealed difficulty to access the clean paper towels for drying hands post handwashing due to the bleach container obstructing the paper towel dispenser. Observations on 4/17/24 at 9:20 AM of the dialysis treatment room floor revealed a covered container labeled as 1:100 bleach solution with clean bleach cloths noted inside, and a blue container with numerous dialysis clamps located next to clean sinks used for handwashing. Observation further revealed difficulty to access the clean paper towels for drying hands post handwashing due to the bleach container obstructing the paper towel dispenser. During an interview on 9:22 AM with Patient Care Technician (PCT) #1 stated, “I don’t know why they are there”.”

“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: 30011 Based on observation, interview, and review of facility policy and procedure, the dialysis facility failed to ensure the correct amount of water was obtained for 2 of 2 chlorine water testings observed. The findings included: Manufacturer’s guidelines “Ultra Low Total Chlorine Test Strips” revealed “1) Collect a fresh 100 ml sample of water in a clean plastic sample cup...”. Observation on 4/15/24 between 1:57 PM and 2:08 PM of the Chlorine water test conducted by Patient Care Technician (PCT) #1 and Registered Nurse (RN) #2 revealed PCT #1 turned on the post carbon worker port for 2 minutes, obtained a clear cup, rinsed the cup 2 times, then obtained an unmeasured amount of water from the post carbon worker port. PCT #1 and RN #2 performed the chlorine test, verified the results; and when asked how much of a water sample was obtained, PCT #1 was unable to state the amount. A syringe was obtained and the amount of water in the sample cup measured to be 93.5 milliters (ml); verified by PCT #1 and RN #2 and not 100 ml (milliter). During an interview on 4/15/24 at 2:05 PM, PCT #1 stated, “I didn’t know how much water I obtained. Normally there’s a black line on the cup but there isn’t one on this cup”. Further observation of the sample cup revealed indented numbered lines on the the cup post measurement. Review of personnel files on 4/18/24 at 12:30 PM revealed PCT #1 was deemed competent to check for residual chlorine on 2/15/24 and RN #2 was deemed competent to check for residual chlorine on 5/12/22. Observation on 4/16/24 between 8:13 AM and 8:18 AM of the Chlorine water test conducted by PCT #2 and RN #3 revealed PCT #2 turned on the post carbon worker port for 2 minutes, obtained a clear cup with a black marker line on it, rinsed the cup 3 times, then obtained an unmeasured amount of water above the black mark on the cup from the post carbon worker port. PCT #2 and RN #3 performed the chlorine test, verified the results and when asked how much water was obtained, PCT #2 stated, “Policy is no less than 100 ml of water is to be used. It can be over 100 mls”. A syringe was obtained and the amount of water in the sample cup measured to be 110 mls of water verified by PCT #2 and RN #3. Review of personnel files on 4/18/24 at 12:30 PM revealed PCT #2 was deemed competent to check for residual chlorine on 1/29/24 and RN #3 was deemed competent to check for residual chlorine on 9/25/23. During an interview on 4/16/24 at 4:57 PM, Biomedical Technician (BMT) #1 stated, “We teach staff to use 100 ml of water to complete the testing”. Facility policy, entitled “Total Chlorine Testing using RPC Ultra Low Total Chlorine Test Strips Procedure” revealed, “Step 2 Collect a fresh 100 ml sample of water in a plastic sample cup...”.”

“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: 30011 Based on interview, record review, and review of facility policy and procedure, the dialysis facility failed to ensure that 1 of 2 Registered Nurses (RN) #2 completed annual total chlorine water testing. The findings include: Review of personnel files on 4/18/24 at 12:30 PM revealed RN #2 was deemed competent to check for residual chlorine on 5/12/22. During an interview on 4/18/24 at 5:00 PM, Biomedical Technician (BMT) #1 stated, “I only have a competency sheet for another facility. I don’t have a competency sheet for Conway”. Facility policy, entitled, “Knowledge, Skills and Competency Evaluation for Clinical Staff” revealed, “Employees are required to successfully complete all skills requirements, including an initial and annual skills validation, within the given timeframe. Employees without current documented competency within the past 365 (three hundred and sixty-five) days may be removed from performing independent direct patient care (DPC) until competency is demonstrated and documented...”.”

“MAINTENANCE PER DFU OR 2X/YR;RECORD CFR(s): 494.50(b)(1) 7.2.3 Maintenance: per DFU or semiannual/maintenance record Written maintenance procedures and a schedule of preventive maintenance activities designed to minimize equipment malfunctions should be established. In the case of purchased reprocessing equipment or safety equipment, the recommendations of the vendor should be followed unless documented experience supports alternative approaches. If the manufacturer’s recommendations are not available, reuse equipment and safety equipment should be inspected on a semiannual basis. 4 Records 4.3 Equipment maintenance record Records shall be maintained of the dates of preventive maintenance procedures and the results of scheduled testing in order to ensure the proper functioning of reprocessing equipment, environmental-control equipment, safety equipment, or other equipment. 4 Records A place should be provided for the signature or other unique mark of identification of the person ...performing preventative maintenance procedures. This Standard is not met as evidenced by: 30011 Based on observation, interview, and review of facility policy, the dialysis facility failed to ensure fire extinguishers were inspected monthly. The findings include: Observation on 4/15/24 at 2:57 PM of the facility treatment room floor revealed 3 fire extinguishers with a tag documented with missing inspections for the month of November 2023, (1) fire extinguisher in the patient waiting area and (1) fire extinguisher in the storage room. Further review of the fire extinguishers tags revealed the extinguishers was checked on 3/08/24 with no date checked for the month of April during the survey. During an interview on 4/16/24 at 4:57 PM Biomedical Technician (BMT) #1 stated, “I check the fire extinguishers. We do monthly checks on the fire extinguishers. The last time I checked them was December”. Facility policy, entitled “Monthly Fire Extinguisher Inspection” revealed, “Fire extinguishers are to be visually inspected monthly...”.”

“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: 30011 Based on observation, interview, and review of facility policy and procedure, the dialysis facility failed to ensure expired supplies were removed from the patient treatment area. The findings include: Observation on 4/15/24 at 2:29 PM to 2:50 PM of the treatment room floor revealed (3) 0.9% (percent) sodium chloride 1000 milliter (ml) bags in the medication area expired 3/24; crash cart (2) 17 gauge safety fistula needles expired 1/31/24, (1) 17 gauge safety fistula needle expired 3/31/24 and (1) standard nasal cannula expired 3/31/24, and the patient disaster emergency boxes (3) chloraprep single swabsticks expired 3/24. During an interview on 4/15/24 at 2:53 PM, Registered Nurse (RN) #1 verified the findings. Facility policy, entitled “Expiration Dates Sterile Supplies” revealed, “Sterile items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached the expiration date”.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 30011 Based on observation, interview and review of facility policy and procedure, the dialysis facility failed to ensure that 1 of 2 Registered Nurses observed, (RN #3), administered Venofer per guidelines. The findings included: Review of facility policy, entitled “Special Considerations: Venofer” revealed, “Venofer may be administered undiluted as a slow intravenous injection over 2 to 5 minutes...”. Observation on 4/16/24 between 10:37 AM and 10:41 AM revealed RN #3 had aseptically withdrew Venofer from a single dose vial and Heparin from a multi dose vial, then transported the medications by hand to dialysis station #1. RN #3 wiped the injection port at 10:40 AM, and administered both the Venofer and Heparin by 10:41 AM, which was only 1 minute from time of arrival to station to administration. During an interview on 4/16/24 at 4:40 AM, RN #3 stated, “Iron is supposed to be given over 3 to 5 minutes”.”