032597 San Carlos Dialysis (Fmc)

“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: 22676 Based on observation, interview, and facility policy review, the facility failed to ensure that staff providing care to patients performed hand hygiene in between task. This deficient practice had the potential to result in increased infections in all 64 patients receiving care at this hemodialysis unit. Findings include: Patient Care Technician (PCT) 12 was observed on 09/02/24 at 11:40 AM, coming on to the treatment floor, donning new gloves, going to the patient at station 7, disconnecting his/her blood lines without sanitizing his/her hands prior to donning the gloves. He/she was observed disconnecting the blood lines and taking them to the Bio-hazard receptacle. He/she then went and donned new gloves without using hand sanitizer. He/she then went back to pull the dialysis needles on P10 at 11:50 AM. During an observation on the treatment floor on 09/03/24 the following was observed: At 10:40 AM, Certified Clinical Hemodialysis Technician (CCHT) 8 was seen cannulating patient (P) 1. He/she then removed his/her gloves, removed face shield, and touched his/her face without sanitizing his/her hands. At 11:30 AM, CCHT 8 was observed removing a catheter dressing on P7. CCHT 8 removed his/her gloves and failed to sanitize his/her hands prior to donning new gloves to clean the catheter site and place a new dressing. CCHT8 was further observed removing gloves and failing to sanitize his/her hands prior to donning new gloves, then cleaning the catheter hubs, and attaching the syringes to P 7’s catheter hubs. At 12 NN, during an interview, CCHT8 confirmed the above findings. At 12:10 PM, during an interview, PCT 12 confirmed the above findings. At 12:30 PM, during an interview, Clinic Manager 2 confirmed the staff failed to follow appropriate hand hygiene and they failed to follow the facility’s policy. Review of facility’s policy, titled “Hand Hygiene,” dated 11/06/23, indicated, “Decontaminate using alcohol-based hand rub or with antimicrobial soap and water before and after direct contact with patients, entering and leaving the treatment area, before performing any invasive procedure ...””

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 22676 Based on observation, interview, and record review, the facility failed to restrict access to the water purification and storage system to only authorized users on one of three survey days. Failure to restrict access to the water treatment area had the potential to negatively impact the safety and well-being of the 64 in-center dialysis patients receiving treatments at this facility. Findings include: During the flash tour observation on 09/02/24 at 8:45 AM, it was revealed the door designated as the entrance to both the water purification system and storage system was secured by a keyless entry lock. Upon entering the water treatment area, the door was found standing open and there were no staff in the water room. During concurrent interview, Certified Clinical Hemodialysis Technician (CCHT) 8 confirmed the door was left standing open and that no staff was in the water room. Review of facility’s policy titled, “Physician Security and Facility access” dated 09/05/23, states “Water Treatment Area Security: Restricted access must be maintained to prevent unwanted tampering with the water treatment equipment ...””

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 22676 Based on observation, interview, and review of the facility’s policy, the facility failed to ensure one of one bottle of “SteriCheck Sensitive Low Range Hardness Reagent Test Strips” was dated when opened. This deficient practice had the potential to affect the water quality of the all 64 in-center hemodialysis patients receiving treatment and staff at this facility. Findings include: During a tour of the water room on 09/02/24 at 8:45 AM a bottle of “SteriCheck Sensitive Low Range Hardness Reagent Test Strips” was opened but not dated to indicate when it was opened. In an interview, the Certified Clinical Hemodialysis Technician (CCHT) 8 confirmed that the bottle was opened but not dated to indicate when it was opened. He/she stated that the bottles were supposed to be dated when opened. Review of facility policy titled “Total Hardness Testing with Sterichek Sensitive Low-range Hardness Strips Procedure” dated 10/24/22 states “Inspect test strip bottle and verify strips are not expired (expires six months from the start of opening), date is written on the bottom of the bottle, the bottle is capped securely, and the bottle is dated and initialed.””

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 22676 Based on interview, policy review, and review of the manufacturers direction for use, the facility failed to ensure that one out of one bottle of mesa lab 7.0 Potential Hydrogen (PH) solution and one of one bottle of 14.0 mS/cm (milli siemens per centimeter) used to check the PH and conductivity of the Myron L[sic] D6 meter (a meter used to conduct the conductivity and PH) was dated when opened. This had the potential to cause harm to all 64 in-center hemodialysis patients receiving care at the facility. Findings include: During a tour of the Water Room on 09/02/23 at 8:45 AM the following was found: 1. One bottle of 7.0 mesa lab PH calibration solution was not dated as to when it was opened. Instructions on the side of the bottle directed that it expired ninety-days from opening. The side of the bottle contained a blank to record the date opened and the date expired. 2. One bottle of 14.0 mS/cm conductivity solution was opened but not dated. Instructions on the bottle state the solution expires 30 days from the date of opening. During concurrent interview, the Certified Clinical Hemodialysis Technician (CCHT) 8 confirmed the PH solutions and conductivity solutions were open and not dated to determine the last day the solution was to be used. Review of the facility’s policy titled, “Myron L D6 Maintenance Procedure” dated 09/01/22 indicated, “At the beginning of the day, check conductivity, TDS [sic] (442), and PH solution’s expirations dates ...” Review of Mesa lab manufactures instructions dated 01/23 states “7.0 PH solutions expire 90-days from opening and 14.0 mS/cm solutions expires 30-days form opening.””

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 22676 Based on interview and record review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for four of 10 sampled in-center dialysis patients (Patient [P] 1, P2, P5, and P6). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for all 64 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of P1’s electronic medical record (EMR) revealed a prescribed blood flow rate (BFR) of 350 milliliters per minute (ml/min) and a Dialysate Flow Rate (DFR) of auto flow 2.0 which would be 700 ml/min. Review of one of six “Post Treatment” flowsheets from 08/20/24 through 08/31/24 in the EMR indicated the following: a. On 08/27/24, the DFR was at 800 ml/min from 9:40 AM until 10:49 AM. There was no documented rationale for the change to the prescribed DFR. 2. Review of P2’s EMR revealed a prescribed BFR of 400 ml/min and a DFR of 2.0 ml/min which would be 800 ml/min. Review of two of six “Post Treatment” flowsheets from 08/21/24 through 0902/24 in the EMR indicated the following: a. On 08/26/24 the BFR was documented at 425 ml/min from 7:00 AM until 8:51 AM. b. On 08/30/24 the DFR was documented at 500 ml/min from 6:22 AM until 9:02 AM. There was no documented rationale for the change to the prescribed BFR and DFR. 3. Review of P5’s EMR revealed a prescribed BFR of 400 ml/min and a DFR of 2.0 which would be 800 ml/min. Review of two of six “Post Treatment” flowsheets from 08/15/24 through 08/31/24 in the EMR indicated the following: a. On 08/20/24 the DFR was documented at 600 ml/min from 1:43 PM until 5:26 PM. b. On 08/29/24 the DFR was documented at 500 ml/min from 2:02 PM until 5:29 PM. There was no documented rationale for the change to the prescribed DFR. 4. Review of P6’s EMR revealed a prescribed BFR of 400 ml/min and a DFR of 2.0 which would be 800 ml/min. Review of one of six “Post Treatment” flowsheets from 08/19/24 through 08/30/24 in the EMR indicated the following: a. On 08/19/24 the DFR was documented at 600 ml/min from 1:00 PM until 5:06 PM. There was no documented rationale for the change to the prescribed DFR. During an interview on 09/03/24, at 12NN, Clinic Manager 2 confirmed the above findings and confirmed that the staff did not follow the physician orders. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “Check the prescribed blood flow rate is being achieved or the reason is documented in the medical record if unable to meet prescribed flow rate. Check dialysate flow rate setting is correct, and the correct prescribed flow is being ...””