Fresenius Medical Care Norfolk

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 46466 Based on interviews, medical record and facility documentation review, the facility failed to perform patient emergency drills upon admission for one (1) of eight (8) patient records sampled. The findings include: On 4/2/24, a review of eight (8) patient medical records was conducted. Patient #3’s (Pt. #3) medical record evidenced that Pt. #3 was admitted to the facility on 12/19/23. There was no documented evidence to support that Pt. #3 received fire drill and emergency evacuation training upon admission to the facility. On 4/2/24 at 5:10 p.m., an interview was conducted with Staff Members #1 (SM1) and #3 (SM3). Both verified that there was no documentation regarding Pt. #3 receiving training upon admission. SM3 stated that this patient was cognitively impaired and that staff probably did not perform the orientation because of that reason. SM3 stated that Pt. #3 was unable to disconnect themselves from the dialysis machine. A review of the facility’s policy “Guidelines for Emergency Preparedness”, published 7/3/23, stated in part: “...QAI Documentation: Quarterly, all FKC patients must receive fire drill and emergency evacuation training. Training must be documented in QAI and on the fire drill attendance form. All drills: Fire, emergency evacuation, tabletop and community-based drill must be reviewed and documented in QAI...Patient Education: Facility Staff must educate patients on: -Evacuation procedures, -Emergency Disconnection Procedures...Emergency Preparedness...Consideration should be given to patients with physical or cognitive impairments to ensure they are aware of the emergency drills conducted at the clinic...and include them in the drills as much as possible...”. The findings were discussed with Staff Members #1 and #3 at the exit conference on 4/2/24 at 5:45 p.m.”

“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: 46466 Based on observations and facility document review, the facility staff failed properly label clean and dirty areas and failed to separate contaminated supplies from designated clean areas. The findings include: On 4/1/24 at 2:00 p.m., during the flash tour, two separate counters with sinks were observed. One counter was located across from the entrance to the treatment floor. The sink was not labeled and did not have soap or paper towels. A sign was placed on that counter to indicate that personal belongings should not be placed there. The other counter with a sink was located across from patient stations #15 and #16. The sink was not labeled as either dirty or clean. A covered bleach container was located next to the sink. On the other end of the counter, an unlabeled, open container of clamps was found. The container did not indicate if the clamps were dirty or clean. On 4/1/24 at 2:05 p.m., the surveyor observed a sink labeled “clean sink” near an exterior exit door on the treatment floor. On the right side of the “clean sink” was a closed bleach container and to the left side was an open container with dirty clamps. On 4/1/24 at 3:25 p.m., a covered container labeled “clean clamps” was located at a labeled “dirty sink” area on the counter where the lab specimen centrifuge was located. A review of a facility policy “Dialysis Precautions”, published 01/04/2012, stated in part, “...Clean Versus Dirty Areas: Clean area: An area designated for clean and unused equipment, supplies and medications. Dirty area: An area where this {sic} is a potential for contamination with blood or body fluids and area where contaminated or used supplies, equipment, blood supplies or biohazard containers are stored or handled...” The findings were discussed with Staff Members #1 and #3 at the exit conference on 4/2/24 at 5:45 p.m.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 19883 Based on observation, staff interview, and facility document review, the facility staff failed to empty two (2) full biohazard needles/sharps containers per facility policy. The findings included: On 04/02/24 at 11:44 PM, the surveyor observed two (2) biohazard needles/sharps containers filled above the “fill line” and located next to patient stations #16 and #17. Staff Member #10 (SM10) was observed removing a blood-filled syringe from the central venous catheter at station #16. SM10 removed the syringe and had to walk past the two (2) full sharps containers to access an empty container to dispose of the contaminated syringe. An interview was conducted with SM10 after the observation and SM10 confirmed that both sharps containers were full but due to providing patient care SM10 did not have the opportunity to replace the full sharps containers with empty ones in a timely manner. Review of the facility’s policy “General Cleanliness and Infection Control Guidelines”, published 02/07/22, reads in part: “ ...All containers for storage or disposal of needles/sharps shall be replaced on a regularly scheduled basis or when no more than 2/3 to 3/4 full. The containers must be closed prior to being full and prior to being disposed ...”. The findings were discussed with Staff Members #1 and #3 at the exit conference on 4/2/24 at 5:45 p.m.”

“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: 46466 Based on observations and facility document review, it was determined that the facility’s staff failed to A, clean and disinfect contaminated surfaces of the medical devices and equipment per facility policy; B, clearly identify areas as clean/dirty; and C, label “Bleach Solution” container according to facility policy. The findings included: On 4/1/24 at 2:00 p.m., a container filled with clamps was found on the counter across from patient stations #15 and #16. The container was not labeled as either clean or dirty. On 4/1/24 at 2:05 p.m., a bleach container located by a clean sink adjacent to exterior exit door was not labeled with the current date, time or initials of the staff member who mixed it. On 4/2/24 at 2:45 p.m., Staff Member #15 (SM15) was observed cleaning patient station #15. SM15 disinfected the dialysis machine while the patient remained in the chair at the station. On 4/2/24 at 3:20 p.m., SM15 was observed cleaning patient station #14. SM15 disinfected the dialysis machine while the patient remained in the chair at the station. A review of the facility’s policy “Cleaning and Disinfecting the Dialysis Station”, published 9/5/23, stated in part: “...Vacating the Machine: To prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfection of the satin and set up for the next person...Cleaning Clamps: Place used plastic pressure clamps and plastic hemostat clamps in a labeled opaque plastic container filled with 1:100 bleach solution per the Mixing Bleach policy...”. A review of the facility’s “Mixing Bleach” procedure, published 8/25/20, stated in part: “...4. Label opaque container with “Bleach Solution”, strength of solution, date and time prepared and your initials. 5. Cover opaque container with lid. 6. Discard solution daily at end of treatment day or more often if needed”. The findings were discussed with Staff Members #1 and #3 at the exit conference on 4/2/24 at 5:45 p.m.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 46466 Based on observations and facility document review, the facility staff failed to maintain a safe environment for dialysis patients by not discarding expired medications and not properly labeling previously drawn medications. The findings include: On 4/1/24 at 2:00 p.m., four (4) syringes filled with medications were found inside the medication refrigerator. The syringes were labeled with patient information and date, but did not include the time and the initials of the staff member who drew the medications. Six (6) vials of expired parsabiv medication were also found the refrigerator. The vials expired on 1/2024. The refrigerator also contained a vial of Tubersol with an opened date of 2/23/24. The Tubersol package insert reads “A vial of Tubersol which has been entered and in use for 30 days should be discarded. Do not use after expiration date”. A review of the facility’s policy “Medication Preparation and Administration”, published 2/6/23, stated in part “...All medications in syringes not being administered immediately shall be labeled appropriately with the...time and initials of the person who prepared the medication...Expiration dates for all stored medications are to be monitored on a monthly basis. -Expired medications are to be discarded...”. The findings were discussed with Staff Members #1 and #3 at the exit conference on 4/2/24 at 5:45 p.m.”

“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: 46466 Based on interviews and facility document review, the facility staff failed to ensure that color blind testing was performed and documented before staff conducted chlorine test readings in one (1) out of three (3) employee personnel records sampled. The findings include: On 4/2/24 at 3:00 p.m., a review of three (3) personnel records was conducted. The documentation evidenced that Staff Member #15 (SM15) was hired on 2/15/24. SM15’s color blind testing wasn’t administered until 4/2/24. A review of the facility’s water room chlorine testing log was conducted at that time and revealed documentation that SM15 either performed or verified chlorine test readings on several days between 2/17/24 through 3/30/24. On 4/2/24 at 3:45 p.m., an interview was conducted with Staff Member #3 (SM3). SM3 confirmed that SM15 should have been administered a color blind test prior to performing/reading chlorine test strips. A review of the facility’s policy “Color Blindness Testing”, published 1/23/19 stated in part: “...Patient care and biomedical staff are in positions that require the ability to interpret or distinguish color when performing water and/or other quality tests or maintenance on dialysis or other equipment...New hire, rehire, or transfer staff working in a direct patient care or biomedical position are required to take the Ishihara Test for Color Blindness to ensure the ability to perform the essential functions of their job...”. The findings were discussed with Staff Members #1 and #3 at the exit conference on 4/2/24 at 5:45 p.m.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 19883 Based on medical record review, facility document review, and staff interview, the facility staff failed to follow physician’s orders for the prescribed dose of dialysis BFR (blood flow rate) and/or DFR (dialysis flow rate) for four (4) of eight (8) in-center dialysis patients included in the sample. The findings include: Patient #7: The surveyor reviewed six (6) dialysis treatment records from 03/18/24 through 04/01/24 for patient #7. The treatment sheets evidenced an order for a BFR of 450. The treatment records evidenced the following: On 03/20/24, the BFR was documented as 400. On 03/22/24, the BFR was documented as 400. On 03/27/24, the BFR was documented as 400. On 03/29/24, the BFR was documented as 400. On 04/01/24, the BFR was documented as 400. Patient #7’s clinical record failed to contain evidence of documentation explaining why the BFR was changed and not administered as prescribed. Patient #8: The surveyor reviewed six (6) dialysis treatment records from 3/15/24 through 03/29/24 for patient #8. The treatment sheets evidenced an order for a BFR of 400 and a DFR for 800. The treatment records evidenced the following: On 03/15/24, the DFR was documented as 700. On 03/29/24, the BFR was documented as 350. Patient #8’s clinical record failed to contain evidence of documentation explaining why the BFR and DFR was not administered as prescribed. On 4/2/24 at 5:15 p.m., Staff Member #3 reviewed the dialysis treatment records of Patients #1, #4, #7 and #8 and verified that there was no documentation explaining why the BFR’s and DFR was not administered as prescribed. 46466 Patient #1 (Pt. #1): The surveyor reviewed six (6) dialysis treatment records from 3/19/24 through 3/30/24. The treatment sheets evidenced an order for a BFR of 400. On 3/26/24, the BFR was documented as 350. On 3/30/24, the BFR was documented as 350. Pt. #1’s clinical record failed to contain evidence of documentation explaining why the BFR was not being administered as prescribed. Patient #4 (Pt. #4): The surveyor reviewed six (6) dialysis treatment records from 3/19/24 through 3/30/24. The treatment records evidenced an order for a BFR of 450. On 3/19/24, the BFR was documented as 400 On 3/21/24, the BFR was documented as 400 On 3/26/24, the BFR was documented as 400. Pt. #4’s clinical record failed to contain evidence of documentation explaining why the BFR was not being administered as prescribed. A review of the facility’s policy “Patient Assessment and Monitoring”, published 5/1/23, stated in part: “...3. Machine Parameters and Extracorpeal Circuit - Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in the medical record if unable to meet prescribed blood flow... - Check dialysate flow rate setting is correct, and the prescribed flow is being delivered...4. Document any findings and interventions in the medical record...”. The findings were discussed with Staff Members #1 and #3 at the exit conference on 4/2/24 at 5:45 p.m.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 46466 Based on observation and facility policy review, the facility staff failed to use aseptic technique when accessing an arteriovenous (AV) fistula/graft and failed to ask patients to clean their access sites prior to treatment per facility policy. The findings included: On 4/2/24 at 10:20 a.m., the surveyor observed a staff member preparing to access patient’s AV site at station #12. The staff member wiped the AV site with antiseptic, palpated the access site and inserted the cannulation needle without reapplying antiseptic to the AV site after palpating. On 4/2/24 at 10:07 a.m. and 10:10 a.m., the surveyor observed two (2) patients entering the treatment floor prior to their treatment. Both patients were weighed by two different staff members. Neither staff member asked the patients to wash their access sites prior to initiating their treatment. A review of the facility’s policy “Access Assessment and Cannulation”, published 7/5/22 stated in part: “...Assessment of Vascular Access...Step 1. Prior to treatment, ask patient to wash access area with soap per hand hygiene procedure. Wash access (per above) if patients unable to clean their access...Skin Disinfection...Step 2. Perform skin antisepsis on one site at a time, allow to dry and then {sic} cannulate. Do not touch cannulation sites after skin disinfection...”. The findings were discussed with Staff Members #1 and #3 at the exit conference on 4/2/24 at 5:45 p.m.”