322504 Albuquerque Kidney Center (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 used appropriate hand hygiene. This deficient practice had the potential to result in increased infections in all 87 patients receiving care at this hemodialysis unit. Findings include: During an observation on the treatment floor on 07/18/24 at 10:00 AM, Registered Nurse (RN) 8 was seen their waving hands in the air to dry hand sanitizer prior to donning gloves and going to Patient (P) 10 at Station #8. RN8 was then seen touching the machine, set machine setting for P10. RN8 was then seen disconnecting the Central Venous Catheter (CVC) without changing gloves and using hand sanitizer prior to the final disconnect of the CVC. An interview with RN8 on 07/18/24 at 10:40 AM confirmed he/she did wave hands in the air to dry the hand sanitizer and failed to change gloves after touching the machine setting and making the final disconnect. On 07/18/24 at 10:50 AM, Patient Care Technician (PCT) 14 was observed was observed providing care to P8 at Station 12. He/she was observed disconnecting the blood lines and taking them to the Bio-hazard receptacle. He/she then removed gloves and touched hair and removed goggles without using hand sanitizer. He/she then went and donned new gloves without using hand sanitizer. He/she then went back to pull the dialysis needles on P8. On 07/18/24 at 10:55 AM, PCT14 was then seen removing gloves, using hand sanitizer, and waving hands in the air to dry the hand sanitizer. PCT14 then went to P9 at Station 14 and disconnected the blood lines and disposing of them. He/she then removed gloves and failed to use hand sanitizer. He/she then donned new gloves and pulled P9 needles. PCT14 was also observed touching his/her hair several times during the observations prior to donning gloves. On 07/18/24 at 11:15 AM Certified Hemodialysis Technician (CCHT) 12 was observed at the cart in the center of the room. He/she was observed using hand sanitizer and waving his/her hands in the air prior to donning gloves. An interview was conducted with CCHT12 at 11:15 AM, he/she confirmed he/she waved hands in the air before putting on the gloves. Interview with PCT14 on 07/18/24 at 11:00 AM, he/she confirmed the above findings. PCT14 stated he/she will try to remember to use hand sanitizer after removing gloves. An interview with Clinic Manager 2 on 07/18/24 at 1:30 PM 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, “Allow alcohol to dry completely allows adequate contact time to kill germs .... Decontaminate using alcohol-based hand rub or with antimicrobial soap ...Immediately after removing gloves ...””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 22676 Based on observation, interview and policy review, the facility failed to date and initial two out of two open vials of medication found in the medication area. These findings have the potential to increase infections in all 87 in-center patients receiving care in the facility by exposing them to medication used passed the allowed dated. Findings. During a tour of the treatment unit on 07/17/24 at 3:00 PM an unattended bottle of Heparin 30,000 units (a medication to prevent blood clotting) was found opened but not dated. During an interview on 07/17/24 at 3:00 PM with the Clinic Manager confirmed the bottle of Heparin was opened but not dated or initialed. During observation on the treatment unit on 07/18/24 at 11:55 AM, a vial of doxecalciferol 4 milligrams (mg) (a medication to treat high parathyroid hormone level) was found opened but not dated. During an interview with Registered Nurse (RN) 9 on 07/18/24 at 12:30 PM confirmed the vial of doxecalciferol was opened but not dated or initialed. He/she stated that he/she opened that vial that morning but forgot to initial and date it. Review of facility’s policy titled, “Medication Preparation and Administration,” dated 02/06/23, indicated, “To ensure all open vials are properly marked, the nurse must never walk away from an opened multi-dose vial without writing the date and time the vial was opened.””

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 22676 Based on interview, document review, and policy review, the facility failed to monitor and ensure one of one brine salt tanks were least half full of salt pellets. (Brine is a concentrated saline solution used to flush the resin bed of a water softener.) These findings had the potential to cause harm to all 87 in-center hemodialysis patients receiving care at the facility. Findings include: Observation of the brine salt tank on 07/17/24 at 2:30 PM, the tank was not half full of salt pellets and the water in the tank was approximately eight inches above the salt. In an interview with the Biomedical Technician 6 on 07/26/24 at 2:30 PM he/she confirmed the water in the brine tank was approximately eight inches above the salt level. He/she stated they were in the process of installing a new system and that would correct the problem. Review of the facility’s policy titled, “Water Softener,” dated 05/03/23 indicated, “At a minimum, facility staff will monitor and document water softener(s) for the following each operational day: Check brine tank daily to be sure the tank is at least half filled with salt, adding salt pellets if necessary.””

“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 interview, review of the “Daily Water Treatment Logs,” and the facility’s policy, the facility failed to ensure staff monitored the end of day hardness of water quality as required by the regulations and facility policy for four days of 52 days reviewed (05/06/24, 05/10/24, 05/31/24 and 06/11/24). This deficient practice had the potential to affect the water quality of the all 87 in-center hemodialysis patients receiving treatment and staff at this facility. Findings include: Review of the facilities electronic “Daily Water Treatment Logs” titled, “Water Softener,” from 05/01//24 through 06/30/24, located in the electronic waterlogs, revealed the facility failed to conduct the end of day hardness on 05/06/24, 05/10/24, 05/31/24 and 06/11/24. The area to document the end of the day hardness were left blank. During an interview on 07/17/24 at 3:15 PM, Clinic Manager and the Biomedical Technician 6 confirmed staff are required to conduct and document, the end of day hardness (a test to confirm the water hardness does not exceed the required limits) on the daily water treatment log at the end of each treatment day. They both confirmed that on 05/06/24, 05/10/24, 05/31/24 and 06/11/24 the staff failed to document evidence of the end of day hardness. A review of the facility’s policy titled, “Water Softener,” dated 05/03/23, revealed, “Hardness levels post water softener at the beginning of each operational day and at the end of each operational day.””

“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: 22676 Based on observation, interview, review of the “Daily Water Treatment Logs,” and the facility’s policy, the facility failed to ensure staff monitored the chlorine after the first carbon tank every four hours as required by the regulations and facility’s policy for two days of 47 days reviewed (06/03/24 and 06/19/24). This deficient practice had the potential to cause harm to all 87 patients receiving dialysis at the facility by exposing them to harmful chlorine. Findings include: Review of the facility’s electronic “Daily Water Treatment Logs titled Post Worker Carbon Tank” from 05/01/24 through 06/30/24, located in the electronic waterlogs, revealed the facility failed to conduct the chlorine test every four hours as required by Federal Regulations and the facility’s policy. On 06/03/24, staff conducted the chlorine test at 11:40 AM and did not recheck the chlorine until 5:03 PM. Five hours and 59 minutes later. On 06/19/24, staff conducted the chlorine test at 8:53 AM and did not recheck the chlorine until 1:53 PM. Five hours later. During an interview on 07/17/24 at 3:15 PM, Clinic Manager 2 and the Biomedical Technician 6 confirmed staff are required to conduct the chlorine test every four hours. They both confirmed that staff did not conduct the chlorine test as required every four hours. Clinic Manager 2 stated they had recently identified the issue and implemented a corrective action plan on 06/26/24 which will be reviewed in the July Quality meeting. A review of the facility’s policy titled, “Carbon Filtration Monitoring for Incenter Water System Policy” dated 11/07/22, revealed, “When to Test ...at a minimum of every four hours.””

“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 observation, interview, policy review, and review of the manufacturers direction for use, the facility failed to follow the manufacturer’s instructions when they failed to dispose of an opened bottle combined 14 mS (millisecond) Conductivity solution/7.00 pH (a chemical symbol for potential hydrogen which confirms the acid of base of a concentrate) after 30 days. This finding had the potential to cause harm to all 87 in-center hemodialysis patients receiving care at the facility by failure to identify abnormal conductivity reading of the dialysate. Findings include: During tour of the water room on 07/17/24 at 2:30 PM, one bottle of combined 14 mS Conductivity/7.0 pH solution was observed opened and dated 04/01/24. The bottle was not initialed as to who opened the bottle. Review of the manufacturer’s instructions on the bottle indicated to discard 30 days after opening. During an interview on 07/17/24 at 2:30 PM, the Clinic Manager 2 and the Biomedical Technician confirmed the bottle of combined 14 mS Conductivity/7.0 pH solution was dated as being opened on 04/01/24 but not initialed as to who opened the bottle. They both confirmed the bottle was used that morning to calibrate the Myron L D 6 meter. Review of the facility’s policy titled, “Myron L D6 Meter Maintenance procedures Checking Conductivity,” dated 09/01/22, indicated, “Discard expired solutions or solutions without a cap. Use unexpired meter solutions for meter verification ...” Review of “manufactures instruction” for Mesa Laboratories solution indicated, “Shelf life of opened bottle is 30 days from date of opening.””

“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: 22676 Based on review of glucometer logs, interview, facility policy review and manufacturer’s instructions review, the facility failed to: (1.) Ensure the glucometer was in the control range and follow manufacturer’s instructions for one of 30 days reviewed (2.) Conduct the low and high range for 11 of 30 days the clinic was opened, and (3.) Failed to ensure one of one bottle of WaterCheck RC (residual chlorine test strips) was properly labeled when opened. These deficient practices have the potential to provide incorrect blood glucose results which can cause harm by failure to provide treatment for abnormal blood glucose levels resulting in harm to all 87 patients who were receiving in-center hemodialysis at the facility as well as fail to detect the clearance of bleach from the dialysis machine after disinfection. Findings included: 1. Review of the “Blood Glucose Logs,” provided by the facility from 06/01/24 through 06/30/24, revealed the acceptable low blood glucose control range should be 94-126. On 06/014/23, the recorded low control was 94. 2. In addition, staff failed to document the low and high glucometer controls for 06/01/24, 06/06/24, 06/07/24, 06/08/24, 06/13/24, 06/17/24, 06/24/24, 06/25/24, and 06/28/24. 3. During a tour of the water room on 07/17/24 at 2:30 PM a bottle to WaterCheck RC was found open and not dated. During an interview on 07/17/24 at 2:30 PM, Biomedical Technician 6 confirmed staff did not repeat the low-level calibration of the above abnormal levels and failed to document the low and high controls for the above listed days in addition he/she confirmed the bottle of WaterCheck was opened and not dated. During an interview with the Clinic Manager on 07/17/24 at 3:00 PM, confirmed the recorded quality control was out of range and that there was no evidence of the quality control was repeated. The Clinic Manager also confirmed that there was no evidence that staff conducted the control on the above-listed days. Review of the facility’s policy titled, “Blood Glucose Monitoring Device,” dated “11/06/23, indicated, “Calibration control testing shall be performed at the frequency per manufacture’s recommendations. Record test results in the electronic documentation system. Calibration and control testing shall be performed each operation day ...” Review of the “Embrace Pro” glucose monitoring system manufactures instruction revision date 09/20 revealed, “ ...p. eleven, if the test fall outside the range printed on the test strip vial, repeat the test ...” Review of the facility’s policy titled, “Testing for Residual Bleach using WaterCheck RC Residual Chlorine Reagent Test Strips,” dated 05/02/24, indicated,”The opened bottle of test strips will expire three months after the bottle is opened or on the manufactures expiration date, whichever comes first.” Review of the manufacturer’s instructions for WaterCheck RC indicated, “Use the strips within three months of 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 medical record reviews, interview, and policy 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 eight sampled in-center dialysis patients (Patient (P)1, P3, P4 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 87 patients receiving in-center dialysis treatments at this facility. Findings include: 1. A review of P1’s electronic medical record (EMR) revealed a prescribed Dialysate Flow Rate (DFR) of 600 milliliters per minute (ml/min). A review of two of six “Post Treatment” flowsheets from 07/04/24 through 07/16/24 in the EMR indicated the following: a. On 07/09/24, the DFR was documented at 800 ml/min from 6:12 AM until 9:03 AM. b. On 07/13/24, the DFR was documented at 800 ml/min from 7:06 AM through 11:03 AM. There was no documented rationale for the change to the prescribed DFR. 2. A review of P3’s EMR revealed a prescribed DFR was 600 ml/min. A review of two of six “Post Treatment” flowsheets from 06/20/24 through 07/16/24, in the EMR indicated the following: a. On 06/22/24, the DFR was documented at 800 ml/min from 12:39 PM until 10:50 AM. b. On 07/13/24, the DFR was documented at 800 ml/min from 11:49 AM to 2:47 PM. There was no documented rationale for the change to the prescribed DFR. 3. A review of P4 s EMR revealed a prescribed DFR was 700 ml/min. A review of two of five “Post Treatment” flowsheets from 07/08/24 through 07/17/24, in the EMR indicated the following: a. On 07/12/24 DFR was documented at 800 ml/min from 10:25 AM until 1:32 PM. b On 07/15/24 DFR was documented at 800 ml/min from 1:30 PM until 2:14 PM. There was no documented rationale for the change to the prescribed DFR. 4. A review of P6 s EMR revealed a prescribed DFR was 500 ml/min. A review of one of six “Post Treatment” flowsheets from 06/26/24 through 07/15/24, in the EMR indicated the following: a. On 07/08/24 DFR was documented at 800 ml/min from 5:38 PM until 8:00 PM. There was no documented rationale for the change to the prescribed DFR. During an interview on 07/18/24 at 11:15 AM, the Clinic Manager 2 confirmed the above findings and confirmed that the staff did not follow the physician’s order for dialysis treatment. A review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “Check dialysate flow rate setting is correct, and the correct prescribed flow is being delivered ...””