Fmc Pee Dee Dialysis Center

“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: 30011 Based on observations and interview, the dialysis facility failed to ensure the patient’s dialysis treatment sheets were not placed on the top of the patient dialysis machines. The findings include: Observations on 01/17/24 at 1:25 PM to 1:58 PM in the dialysis treatment room revealed dialysis treatment sheets were laid on the top of the dialysis machines at dialysis station 10 A, 12 A, 14 A, 16 A, 1 A, 2 A, 3 A, 4 A, 5 A, 6 A, 1 B, 2 B, 3 B, 4 B, 5 B, 8 B and 9 B. During an interview on 01/17/24 at 2:00 PM, CCHT 2 stated, “Our Internet is down, and we have to convert to the dialysis treatment sheets. The dialysis treatment sheets are placed in the patients charts once we finish with them. We don’t have a way to clean the sheets when we put them up 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 observations, record reviews, and interviews, the dialysis facility failed to ensure 1 of 1 Certified Clinical Hemodialysis Technician (CCHT) and 1 of 1 Registered Nurses (RN) performed the correct procedure for testing of the facility water system for the presence of Chlorine/Chloramines. (CCHT 1 and RN 2) The findings include: Observations on 01/16/24 at 9:59 AM to 10:01 AM of the quality water testing for Chlorine/Chloramines revealed CCHT 1 obtained a pre-measured clear cup, rinsed the cup 1 time from a sample box with a port labeled TCL 2 (post Carbon tank 2 port), obtained a sample of water above the 100 ml (milliliter) line from post carbon tank 2 port instead of the port after primary carbon 1 tank, and completed the remaining process correctly. During an interview on 01/16/24 at 10:02 AM, CCHT 1 stated, “I’m the backup to the main water room person. I did get the sample from the port labeled as TCL 2”. During an interview on 01/17/24 at 1:25 PM, RN 2 stated, “I check the water quite often, and I don’t know what the confusion was yesterday, but I know we check the water from the TCL 1 port (the port after the primary Carbon tank 1)”. Review of CCHT 1’s personnel file on 01/18/24 at 12:24 PM revealed CCHT 1 was deemed competent for “Total Chlorine Testing with RPC Ultra Low Total Chlorine Test Strips” on 07/24/23. Review of RN 2’s personnel file on 01/18/24 at 12:30 PM revealed RN 2 was deemed competent for “Total Chlorine Testing with RPC Ultra Low Total Chlorine Test Strips” on 07/19/23.”

“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 observations, interview, and review of the facility’s policy and procedure, the dialysis facility failed to ensure expired supplies were removed from the patient treatment area. The findings include: Observations on 01/16/24 at 1:15 PM in the dialysis treatment room revealed the following expired supplies: (5) Chloraprep swabs expired 03/22, (2) Chloraprep swabs expired 08/22, (3) Chloraprep swabs expired 07/22, (3) Chloraprep swabs expired 05/23, and (5) Chloraprep swabs expired 02/22). During an interview on 01/17/24 at 1:20 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...”.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 30011 Based on observations, record reviews, and interview, the dialysis facility failed to ensure preventative maintenance was completed annually for the facility water system backflow preventer. The findings include: Observations on 01/17/24 at 10:15 AM in the facility’s water system treatment room revealed the backflow preventer had no preventative maintenance tag for inspection. Review of the facility’s outside vendor inspection report dated 10/05/23 revealed “relief valve is dumping. Inspection cannot be completed repair needed.” During an interview on 01/17/24 at 10:20 AM, the Biomedical Technician (BMT) stated, “They weren’t going to repair since we are getting a new water system.” During an interview on 01/17/24 at 11:15 AM, the Area Technical Manager (ATOM) stated, “We are getting a new water system for this clinic, but I wasn’t aware about this. We will get it fixed”.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 30011 Based on record reviews and interview, the dialysis facility failed to ensure the Quality Assessment Performance Improvement (QAPI) Committee evaluated and analyzed all patient deaths for potential trends in causes of patient deaths. The findings include: Record review on 01/18/24 at 2:23 PM of the facility’s Quality Assessment Improvement (QAI) monthly meeting minutes revealed no documentation of an evaluation and/or analysis of patient deaths for the month of August 2023, September 2023, October 2023, November 2023 and December 2023. During an interview on 01/18/24 at 2:45 PM, the Clinic Manager (CM) stated, “We just review the patient’s admission and discharge diagnosis from the hospital.””