Fmc West Essex

“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: 37656 Based on two of two observations, staff interviews, and review of facility policy, it was determined that the facility failed to clearly designate clean areas from dirty areas in order to avoid possible cross contamination. Findings include: On 5/9/24 at 10:55 AM, an opened jug, approximately two thirds (2/3) full of Naturalyte 2.0 K (Potassium), 2.25 Ca (Calcium) acid solution, was on the top shelf of a gray cart located behind the Nurse’s Station and across from Station 16. The jug did not contain a label with the date of opening. The jug was stored on the shelf containing unopened jugs of Naturalyte 3.0 K, 3.0 Ca acid solution. Upon interview at 11:00 AM, Staff (S)5, a Patient Care Technician, stated that the open jug of acid should have been discarded and not stored in the clean cart containing unopened jugs 3.0 K, 3.0 Ca. S5 confirmed that the gray cart was a clean utility cart. After interview, S5 discarded the acid jug with 2.0 K, 2.25 Ca by pouring it in the dirty sink. 48966 During a tour of the hemodialysis treatment area on 5/29/24 starting at 10:55 AM, the following was observed: A clear rectangular bucket labeled as containing 1:100 bleach was on a two tiered cart located across from Station 17. Next to the bleach bucket were packages of unused clean wipes. Adjacent to the unused clean wipes was a clear rectangular bucket containing dirty clamps. A sign underneath it stated, “20 minutes-clamps soak open position submerged and cover.” Four new, unopened Naturalyte 1 K (Potassium), 2.5 Ca (Calcium) acid jugs were on the second shelf of the cart. This created an area where both clean items and dirty items were stored. During an interview on 5/29/24 at 10:56 AM, S4, a Patient Care Technician, confirmed that the clear rectangular container, located next to the wipes, contained dirty clamps. S4 stated, “We don’t have a separate cart for dirty clamps.” During an interview on 5/29/24 at 11:44 AM, S7, the Charge Nurse, confirmed that the clear rectangular container, located next to the wipes, contained dirty clamps. S7 stated he/she was not sure if the cart was considered clean or dirty. S7 would check with S1, the Clinic Manager, for guidance. At 11:05 AM, the dirty sink across from Station 13 had a 1:100 bleach solution dispenser to the right of the faucet and a bleach jug to the left of the faucet. Two blue clamps were in the dirty sink. Next to the bleach solution dispenser and the dirty sink were three disposable pads on the countertop with two blue clamps in the open position. There were six clear containers with clean, blue clamps, white access clamps, and bicarbonate wands on the dirty sink countertop. This created an area where both clean items and dirty item were stored. During an interview on 5/29/24 at 11:14 AM, S5, a Patient Care Technician, confirmed that the sink across from Station 13 was designated as a dirty sink, that the two blue clamps on the disposable pads were clean, and that the six containers next to the dirty sink contained clean supplies. During an interview on 5/29/24 at 11:40 AM, S7, confirmed that the sink across from Station 13 was a dirty sink. S7 stated that the two blue clamps on the disposable pad should not be next to the dirty sink. S7 stated that as long as the containers with clean supplies had lids, it was acceptable for the containers to be at the dirty sink area. A review of the facility policy titled, “Dialysis Precautions,” published 1/4/12, stated, “... Clean Versus Dirty Area: Clean area: An area designated for clean and unused equipment, supplies and medications. Dirty area: An area where this is a potential for contamination with blood or body fluids and areas where contaminated or used supplies, equipment, blood supplies or biohazard containers are stored and handled. Clean areas should be clearly designated for the preparation and handling of medications and unused supplies and equipment. Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled or stored ...” A review of the facility policy titled, “Acid Concentrate Storage and Handling,” published 7/3/23, stated, “... Concentrate Container Labeling ... Post Treatment: If acid will be stored for future use ... externally disinfect the gallon jug with wand still in place using 1:100 bleach cloth ... Return the container to the designated storage area. Open, labeled concentrate must be stored separately on a properly labeled location. Do not return the opened acid to the same shelf as the unopened acid concentrate. ... If not able to meet requirements, discard acid concentrate after treatment. ...” N.J.A.C 8:43A-24.8(b)”

“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: 48966 Based on a review of patients tested for Hepatitis B surface Antibody (Anti-HBs) of less than 10 mIU/mL (milli-international units per milliliter), staff interview, and facility document review, it was determined that the facility failed to ensure that three of 66 patients (Patient (P)6, P14, P15) who are susceptible to the Hepatitis B Virus, are tested for the Hepatitis B surface Antigen (HBsAg) monthly. Findings include: A review of the Laboratory Results/Medication Administration Summary report indicated the following: P6 had Anti-HBs test result less than 10 mIU/mL on 1/18/24, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg monthly test in January 2024. P14 had Anti-HBs test result less than 10 mIU/mL on 8/17/23, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg monthly test in September 2023. P15 had Anti-HBs test result less than 10 mIU/mL on 8/16/23, which indicated he/she was susceptible to Hepatitis B. The medical record lacked evidence of a HBsAg monthly test in September 2023, October 2023 and November 2023. The above findings were reviewed with Staff (S)7, the Charge Nurse at 12:50 PM on 5/30/23. S7 stated that the testing for Hepatitis HBsAg was not performed monthly on the patients mentioned above and that the missing Hepatitis HBsAg results was an oversight or an improper order. S7 stated that the above mentioned patients should have been tested for Hepatitis HBsAg. A review of the policy titled, “Patient Hepatitis B Testing Requirements,” published 2/7/22, stated, “... HBV Patient Testing: Hepatitis B laboratory testing is required for all patients based upon immunity status ... Patient status, Susceptible HBsAg: Negative, Anti-HBs: less than 10 mIU/ml ... HBsAg monthly testing ...” N.J.A.C. 8:43A-24.4(b)”

“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: 49828 Based on observation and staff interview, it was determined that the facility failed to ensure that manufacturer’s instructions are implemented for pH (potential of hydrogen) testing for one (1) of the two (2) pH tests observed. Findings include: On 5/29/24 at 10:19 AM, Staff (S)9, a Patient Care Technician (PCT), tested the pH on the hemodialysis machine located in Station 19. Inspection of the pH strip bottle revealed a manufacturer’s label with an expiration date of 5/5/24, rendering the strips unusable. At 10:20 AM, S9, confirmed the pH strips were expired and stated that they should not have been used. S9 stated, “I didn’t realize the strips were expired.” He/she then retested the pH levels using unexpired strips. N.J.A.C. 8:43A-24.4(a)”

“MICROB MONITOR-MO DIALYS SAMPLE/COLLECT/FREQ CFR(s): 494.40(a) 7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/freq Culture ...dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year. If testing of any dialysis machine reveals a level of contamination above the action level, an investigation should be conducted that includes retesting the offending machine, reviewing compliance with disinfection and sampling procedures, and evaluating microbiological data for the previous 3 months to look for trends. The medical director also should be notified. An example of a decision tree for this process is given in Figure 1. 7.2.2 Sample collection Dialysate samples should be collected from a dialysate port of the dialyzer ... [or] dialysate sampling ports that can be accessed using a syringe. At least 25 mL of fluid, or the volume specified by the laboratory performing the test, should be collected in sterile endotoxin-free specimen containers. This Standard is not met as evidenced by: 37656 Based on a review of facility documents and staff interview, it was determined that the facility failed to ensure that all scheduled sampling of cultures and endotoxins are performed per facility policy in one out of six months monthly cultures reviewed. Findings include: Staff (S)2, the Biomedical Technician, accompanied this surveyor during a tour of the Water Treatment Room on 5/29/24 starting at 10:05 AM. During the tour, S2 stated that Station 19 was the last station of the distribution loop. On 5/30/24, a review of the monthly microbiological testing schedule indicated that the last hemodialysis station, Station 19, was scheduled to have sampling of water for culture and endotoxin for testing monthly. A review of the culture and endotoxin results indicated that Station 19 was missing a culture and endotoxin results for January 2024. During an interview on 5/29/24 at 2:00 PM, S2 stated that he/she was out on leave around that time and could not find culture and endotoxin result for Station 19 completed in January. A review of facility policy titled, “Microbiological Monitoring of Central Water and Concentrate Mixing and Delivery Systems,” published 3/16/23, stated, “... Scheduled Sampling ... microbiological samples will be collected no less than monthly. ... Sample Locations ... Samples will be collected from the following locations: ... Indirect Feed System Sampling: ... Last sample point of the distribution loop prior to water re-entering the storage pump. ...” N.J.A.C. 8:43A-24.10(a)(1)”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 37656 Based on observation of three of three opened concentrate acid jugs on the treatment floor, staff interviews, and review of facility documents, it was determined the facility medical director failed to implement facility policy to ensure that open acid jugs are properly labeled. Findings include: On 5/29/24, during tour of the dialysis treatment floor, the following was revealed: At 10:27 AM, an opened jug, approximately one third (1/3) full of Naturalyte 2.0 K (Potassium), 3.0 Ca (Calcium) acid solution, was on the chaise wall of Station 13. The container was not labeled with a date of opening and was available for use. Upon interview at the time of discovery, Staff (S) 6, a Patient Care Technician, stated that he/she did not know why it was there and did not know when it was opened. S6 discarded the solution by draining it into the dirty sink. At 10:34 AM, an opened jug, approximately two thirds (2/3) full of Naturalyte 4.0 K, 2.25 Ca acid solution, was on the chaise wall of Station 18. The container was not labeled with the date of opening and was available for use. At 10:55 AM, an opened jug, approximately two thirds (2/3) full of Naturalyte 2.0 K, 2.25 Ca acid solution, was on the top shelf of a gray cart located behind the Nurse’s Station and across from Station 16. The jug did not contain a label with the date of opening. The jug was stored on the shelf containing unopened jugs of Naturalyte 3.0 K, 3.0 Ca acid solution. Upon interview at 11:00 AM, S5, a Patient Care Technician, stated that the open jug of acid should have been discarded and not stored because they do not reuse acid jugs. After interview, S5 discarded the acid jug with 2.0 K, 2.25 Ca and the jug of 4.0 K, 2.25 Ca in the dirty sink. A review of the facility policy titled, “Acid Concentrate Storage and Handling,” published 7/3/23, stated, “... Concentrate Container Labeling ... 1 gallon container: If unused acid will be stored for further use, record on the container the date and time it was opened and the initials of the staff member that opened the container. ... Acid Concentrate Gallon Container ... Prior to treatment: ... Label the acid per policy. ...””