Fresenius Medical Care Walterboro

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 28883 Based on observation, interview and review of facility policy, the dialysis facility staff responsible for monitoring and changing wet trandsucer protectors failed to change 1 of 2 wet transducer protectors timely and failed to inspect the backside of 1 of 2 wet transducer protectors when removed from the machine. The findings include: Cross Reference to V-0120: The dialysis facility failed to ensure that transducers were monitored for wetness and/or breakthrough and changed in a timely manner to prevent potential cross contamination to the patient.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 22313 Based upon observation, record review, interview and facility policy, the dialysis facility failed to ensure that emergency oxygen was available on the treatment floor for patient use. Findings include: Observation of the treatment floor area on 08/20/2024 at 12:03 PM revealed the emergency oxygen tank on the crash cart was found to be open, unlocked and empty. Registered Nurse (RN) #1 had considerable trouble finding the key to turn on the oxygen, then confirmed that the tank was empty. RN #1 then said, “Oh, we can use this one over here that sits chairside”. She/he pulled the second tank over to the crash cart and it was empty as well. Record review on 08/20/2024 at 12:10 PM of the Emergency Equipment & Medications Checklist showed the oxygen was last checked on 08/20/2024 at 04:30 AM and declared “Full”. In an interview on 08/20/2024 at 12:18 PM, RN #1 stated, “I guess whoever checked it off this morning didn’t really check the tank”. Facility policy, entitled “Guidelines for Emergency Preparedness”, published 07/03/23, reads, “The following minimum emergency supplies and equipment must be on the premises at all times, clean, functional, accessible and immediately available: ...Oxygen, tubing and masks, cannulas”.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 22313 Based on observations, interview and facility policy review, the dialysis facility failed to ensure that trash was not overflowing from trash containers onto the treatment room floor. Findings include: Observations on the treatment room floor on 08/21/2024 at 1:32 PM revealed used gloves, wet paper hand towels and other paper debris on the floor in the patient treatment area. In an interview on 08/21/2024 at 1:40 PM, Registered Nurse (RN) #2, responded, “Oh, yeah, that, we get messy. Housekeeping dumps the trash containers for us, not sure when ...” . Facility policy, entitled “General Cleanliness and Infection Control Guidelines”, published 07/01/2024, reads, “All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms and offices. Walkways must be kept clear of debris and free of clutter”.”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 22313 Based on observation, interview and review of facility policy, the dialysis facility failed to ensure that transducers were monitored for wetness and/or breakthrough and changed in a timely manner. Findings include: Observations of the treatment room floor on 08/20/2024 at 12:25 PM revealed a patient with a right central venous catheter (CVC) at Station #13, dialysis machine #23 with a wet transducer. Registered Nurse (RN) #1 was at the station talking to the patient, who had over 1 hour of treatment time left. At 1:00 PM, Patient Care Technician (PCT)#1 was called to the station as the patient was “feeling bad” so she attended the patient and checked the machine, then left, with no changes to the transducer. At 1:15 PM, RN #1 went to the machine and made some adjustments, talked to the patient then laid the patient back in a recumbent position. RN #1 took pedal pulses, noted 2+ swelling of the ankles of the patient, then told the patient that she/he was going to call the doctor with no changes to the transducer with 19 minutes left until the end of treatment. At 1:30 PM, RN #1 returns to the patient and makes machine adjustments, with no changes to the transducer. At 1:45 PM, PCT #1 comes to the machine and makes adjustments with no changes to the transducer. At 1:55 PM, RN #1 returns to the patient at the machine, checks the machine and the patient and ends the patient’s treatment. RN #1 begins removing the used dialysis tubing and was about to place it into the biohazard container without observing the back of the transducer when the nurse surveyor approaches and asks to see the transducer. When asked how long the transducer had been wet, RN #1 responded, “I don’t really know.” When asked what the procedure is for a wet transducer, RN #1 responded, “We are supposed to change them out immediately. If the backside is wet, we have to pull the machine for biomedical to decontaminate”. When asked why the nurse did not check the transducer on her multiple trips to the patient/machine, RN #1 responded, “I guess I just forgot to look at it”. Facility policy, entitled “Maintenance of Transducer Protectors Procedure”, published 11/01/2021, reads, “External transducer protectors must be changed immediately when they become wet with blood or other fluid ...”.”

“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: 22313 Based on observations, interview and facility policy review, the dialysis facility failed to ensure that staff cleaned stethoscopes and/or prime waste containers between patient use. Findings include: Observations on the treatment room floor on 08/21/24 at 9:05 AM revealed Patient Care Technician (PCT) #3 cleaning the equipment at Station #1, Machine #22 post patient treatment. PCT #3 dumped the fluid out of the prime waste container then put the container back on the side of the dialysis machine without disinfecting it. During an interview on 08/21/2024 at 9:10 AM, PCT #3 responded, “Oh, I never do, why?” Observation on 08/21/24 at 9:20 AM of the treatment room floor revealed Registered Nurse (RN) #1 taking the stethoscope from his/her neck and using it on a patient at Station #1 and returned it to his/her neck without disinfection. At 9:20 AM, RN #1 again removed the stethoscope from his/her neck, used it on the patient at Station #3 and returned it to his/her neck without disinfection. At 9:23 AM, RN #1 was observed taking the stethoscope from his/her neck and using it on the patient at Station #2 and returned it to his/her neck without disinfection. At 9:30 AM, RN #1 was observed taking the stethoscope from his/her neck and using it on the patient at Station #2 and returned it to his/her neck without disinfection. During an interview on 08/21/24 at 9:35 AM, RN #1 was asked about disinfecting the stethoscope between patients and responded, “Oh, I guess I should...”. Facility policy, entitled “Cleaning and Disinfecting the Dialysis Station”, published 09/05/2023, reads, “Area including the dialysis machine, chair and other reusable equipment supplies utilized during dialysis treatment ....dialysis machine, attachments, intravenous pole, blood pressure cuff and hand sanitizer/holders ...stethoscope, must be disinfected with 1 part bleach to 100 parts water ( 1:100) bleach solution, or EPA (Environmental Protection Agency) registered disinfectant ...after use”.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 28883 Based on observation and interview, Patient Care Technician (PCT) #2, one of two PCT’s observed initiating a dialysis treatment for a patient with a fistula/graft, failed to ensure aseptic technique had been observed for Patient #8 after a dialysis needle line remained uncapped and susceptible to possible contamination. The findings include: Observation on 8/21/24 at 9:00 AM revealed PCT #2 at machine #1, station #12, initiating a dialysis treatment for Patient #8. After sticking two needles into the patient’s graft, PCT #2 bled down the arterial needle, removed the end cap, and filled lab tubes using a vacutainer. PCT #2 removed the vacutainer from the end of the venous dialysis needle and taped both needle lines to the patient’s arm, leaving the venous needle line uncapped and open to possible contamination. The patient’s sleeve was in close proximity to the open needle line and could have touched the needle line if the patient moved his/her arm. The open needle line could become contaminated as well due to possible droplet contamination/airborne contamination by nasal or oral secretions. The needle line was left open and unsupervised from 9:16 AM until 9:18 AM when Registered Nurse (RN) #3 came and removed the endcap from the venous needle line and administered the medication Heparin to the patient, leaving the syringe attached to the end of the needle line. RN #3 touched the uncapped arterial needle line, moving it out of the way to access the venous needle line, but did not place a sterile cap onto the uncapped arterial needle line. After leaving the patient post administration of the Heparin at 9:19 AM, PCT #2 stopped at the patient’s chairside and left at 9:20 AM stating she/he had to change gloves. PCT #2 did not return to the chairside for Patient #8 until 9:28 AM, leaving the arterial needle uncapped and open to possible contamination. PCT #2 attached the dialysis line to the arterial needle line at 9:33 AM, starting the patient’s dialysis treatment. PCT #2 did not wipe the arterial needle line with antiseptic/disinfectant before attaching the dialysis line to the arterial needle line. During an interview on 8/21/24 at 9:40 AM, PCT #2 verified the above observation. The surveyor discussed the concern that aseptic technique had not been observed by leaving the dialysis needle uncapped and exposed to possible contamination.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 28883 Based on observation, interview, and review of facility policy “Concentrate Labeling Requirements”, the dialysis facility staff failed to ensure the acid mixing tank/bicarbonate mixing tank that contained concentrate had not been labeled with either the concentrate type and/or date of preparation. The findings include: Observation on 8/20/24 at 10:22 AM in the water treatment room revealed a batch of acid in the mixer that was ready to be transferred to the holding tank. The mixer was not labeled with the concentrate type or date of preparation. Observation of the bicarbonate mixer revealed one tank filled with mixed bicarbonate. A label on the back of the machine indicated a batch had been mixed on 12/18/21 at 4:30 AM. During an interview on 8/21/24 at 10:23 AM, the Biomedical Technician verified the findings and stated that it was an old label and bicarbonate is mixed daily. The Biomedical Technician verified there was not a label with a date for that day’s mixing of bicarbonate. Review on 8/21/24 at 12:27 PM of the facility policy, entitled “Concentrate Labeling Requirements”, dated 9/5/23 revealed information that when a mix tank contains a solution, a label identifying the solution must be conspicuously displayed on the tank and must remain until the mix tank is emptied. Mix tank labeling must include contents identification, chemical composition or formulation of concentrate, concentrate family with appropriate symbol, catalog number, and date and time of mixing.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 28883 Based on review of acid mixing logs, interview, and review of facility policy “Acid Concentrate Mixing and Handling, Dry Acid Dissolution Unit”, the dialysis facility nursing staff failed to verify mixing and specific gravity test results with a second staff member for 6 of 8 batches of acid mixed in July and August 2024. The findings include: Review on 8/21/24 at 8:11 AM of the acid mixing logs for July and August 2024 revealed that batches of acid were mixed that did not include a separate staff member verification of mixing and test results on 7/10/24, 7/12/24, 7/19/24, 8/6/24, 8/16/24, and 8/17/24. The log contained information that the reviewer’s employee identification number should be different than the person who mixed the batch. During an interview on 8/21/24 at 12:08 PM, Patient Care Technician (PCT) #3 stated that she/he had not known until recently that a second verifier was required. PCT #3 verified she/he had mixed and verified the batches of acid on 7/10/24, 7/12/24, 8/6/24, and 8/17/24. She/he reviewed the logs and verified the same Patient Care Technician had mixed acid and verified the results on 7/19/24 and 8/16/24. Review on 8/21/24 at 12:30 PM of the facility policy “Acid Concentrate Mixing and Handling, Dry Acid Dissolution Unit”, dated 9/5/23 revealed information that “... Specific Gravity ... will be tested once the mixing process is completed by the operator and verified by a second staff member...”.”

“BICARB MIX SYS-STOR/USE TIME/MIN COMBINE CFR(s): 494.40(a) 5.4.4.3 Bicarbonate concentrate mixing systems: storage/use time limits/min combine Once mixed, bicarbonate concentrate should be used within the time specified by the manufacturer of the concentrate. 7 Strategies for bacterial control 7.1 General Storage times for bicarbonate concentrate should be minimized, as well as the mixing of fresh bicarbonate concentrate with unused portions of concentrate from a previous batch. The manufacturer’s instructions should be followed if they are available. This Standard is not met as evidenced by: 22313 Based upon observation, interview and facility policy, the dialysis facility failed to ensure that expired and open bicarbonate jugs were removed from the Biomedical area. Findings include: Observation of the Biomedical area on 08/20/24 at 10:25 AM revealed (3) jugs of undated bicarbonate concentrate open to air, sitting on the floor around hemodialysis machines that were being repaired/tested. The bicarbonate product label reads, “Once this product is opened and the inner seal broken, the MB-330-L concentrate must be used within 24 hours”. In an interview on 08/20/24 at 10:35 AM, the Biomedical Technician confirmed, saying, “Oh, yeah, those been there for a while. Guess I should’ve thrown those away”. Facility policy, entitled “Storage and handling of Factory Mixed Liquid Bicarbonate”, last revised on 10/24/2022 reads, “Upon opening the container, write the date opened on the container. Any unused bicarbonate concentrate must be discarded at the end of the day when it was opened”.”

“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: 28883 Based on observations, interviews, and review of facility policy “Checking Conductivity and pH of Final Dialysate”, Patient Care Technician (PCT) #2, one of two PCT’s observed initiating a dialysis treatment and performing an independent pH check of the dialysate, failed perform an independent check of the pH prior to the start of the dialysis treatment for Patient #8, and failed to perform the independent check of the pH as per the manufacturer’s instructions on the container for a randomly observed patient. The findings include: Observation on 8/21/24 between 9:00 AM and 9:36 AM revealed PCT #2 at machine #1, station #12, initiating a dialysis treatment for Patient #8. The dialysis machine screen indicated that the machine had passed the test for the independent conductivity check of the dialysate. The machine was attached to the wall box and used a bicarbonate source that had been mixed by the facility staff. PCT #2 failed to perform an independent check of the pH of the dialysate prior to starting the patient’s treatment. During an interview on 8/21/24 at 9:40 AM, PCT #2 verified the observation and stated she/he was used to the dialysis machine doing the independent check of the pH and conductivity. PCT #2 stated that the machines used in this clinic performed the independent conductivity but required the staff to do the independent pH check. Observation on 8/21/24 at 10:20 AM revealed Patient Care Technician #2 at machine #23, station #13 obtaining a dialysate sample to perform an independent pH check before a patient treatment. PCT #2 did not perform the test correctly and swished the pH test strip in dialysate for 6 seconds before reading the result. When asked how long she/he had dipped the test strip in the dialysate, PCT #2 stated “1 minute”. Review of the instructions on the pH test strip container with PCT #2 revealed to dip the test strip in the solution for 1-2 seconds before comparing to the color strip to get the result. Review on 8/22/24 at 7:30 AM of the facility policy “Checking Conductivity and pH of Final Dialysate” revealed information that two staff members will verify the conductivity and pH prior to each patient’s treatment. The 2008 T BlueStar machines will not perform an independent pH calculation when using any other source of bicarbonate (from a mixer or bicarbonate containers). Staff must test the dialysate pH using a different independent method, such as a handheld meter or pH test strip.”

“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: 28883 Based on review of heat and bleach disinfection logs, interview, review of facility policy “Hemodialysis Machines: Acid Clean, Chemical Rinse, and Heat”, and the 2008 T Machine Operator’s Manual, the dialysis facility nursing staff failed to document weekly bleach disinfection for 5 of 9 hemodialysis machine disinfection records reviewed. (Machines #3, #4, #5, #7, and #24). The findings include: Review on 8/20/24 at 11:30 AM of the bleach disinfection logs for August 2024 revealed dialysis machines #3, #4, #5, #7, and #24 did not have a weekly bleach disinfection of the machine documented between 7/31/24 and 8/9/24. Machines #3, #4, #5, #7, and #24 had a documented bleach disinfection on 7/31/24 and then again on 8/9/24 after a “Storm”. During an interview on 8/21/24 at 12:20 PM, Patient Care Technician (PCT) #3 reviewed the log and verified bleach disinfections for the above machines had not been documented. PCT #3 stated the PCT’s perform the bleach disinfection of the hemodialysis machines weekly on Tuesdays. Review on 8/21/24 at 12:35 PM of the facility policy “Hemodialysis Machines: Acid Clean, Chemical Rinse,and Heat”, revealed information that Chemical Rinse (Chemical Disinfection) must be performed a minimum of weekly (every 7 days), using bleach. Review of the 2008 T Machine Operator’s Manual information revealed “The Chemical Rinse program should be used when disinfecting the hydraulic system with corrosive chemicals such as bleach. The Chemical Rinse program consists of a disinfection cycle followed by a water rinse cycle.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 22313 Based on observations, interview, and facility policy, the dialysis facility failed to ensure that patients’ accesses remained in view during treatment times for 1 of 12 patients observed for covered accesses. Findings include: Observation of the treatment room floor on 08/21/24 at 11:25 AM revealed a patient at Station #13, Machine #23 with a central venous catheter (CVC). Observation revealed the patient completely covered from head to toe with a blanket for over 2 hours while the patient received dialysis treatment. At 11:25 AM, Registered Nurse (RN) #1 came to check the patient/machine and failed to uncover the patient’s access site. At 12:05 PM, Patient Care Technician (PCT) #3 checked the machine but did not uncover the patient’s access site. The patient began complaining of feeling bad and nauseated and the chair was reclined but the patient remained totally covered. At 12:31 PM, PCT#1 walked by the patient and picked up items at the station but did not uncover the patient’s access. At 1:00 PM, PCT#3 checked the machine but did not uncover the patient’s access. At 1:15 PM, RN #1 told the patient that she/he was going to call the physician about the nausea, but RN #1 failed to uncover the patient’s access. At 1:30 PM, RN #1 comes back to the patient and checks the machine only then walks away. At 1:45 PM, PCT #1 adjusted the hemodialysis machine with no change to the patient’s access. At 1:52 PM, RN #1 ended the patient’s treatment. During an interview with RN #1 on 08/21/24 at 2:03 PM, RN #1 responded, “Oh yeah, she/he gets cold and just wants to cover up and go to sleep. I don’t disturb her/him”. During an interview on 8/21/2024 at 2:10 PM, PCT #1 responded that “the patient prefers it, what can I do?” Facility policy, entitled “Patient Monitoring and Safety Checks”, published 09/05/2023, reads, “Patients must be under continual observation. Patients will not be left unattended during treatment. Confirm each patient’s face and access are uncovered. Confirm all patient connections are ALWAYS secure and uncovered due to serious risk of exsanguinations that could go undetected if the access was covered”.”

“H-PT CONSULTATION WITH IDT MEMBERS PRN CFR(s): 494.100(c)(1)(iv) Services include, but are not limited to, the following: (iv) Patient consultation with members of the interdisciplinary team, as needed. This Standard is not met as evidenced by: 28883 Based on record review, interview, and review of facility policy “Social Work Services”, the dialysis clinic’s Social Worker failed to document routine contact with Patient #7 and/or his/her family in order to identify potential social services needs that should be addressed. The findings include: The dialysis facility admitted Patient #7 on 12/27/22 to the Home Therapy Department for Home Hemodialysis with a date of birth of 6/7/44. Record review on 8/22/24 at 8:12 AM revealed Social Work documentation dated 1/16/24 of a clinic visit. There was no documentation of phone communication or that the clinic’s Social Worker (SW) attended monthly patient visits to the home therapy department in February and March 2024 to address any potential issues. A Social Work note dated 4/16/24 stated that the clinic SW was on vacation, and that she/he was providing coverage and had been contacted by the spouse who is requesting a letter stating patient is disabled. A brief transplant note dated 5/28/24 did not contain information that any potential issues related to social services had been communicated. A note had been documented by the clinic’s Social Worker on 6/4/24. There was no note documented by the clinic Social Worker for July 2024 or as of August 22, 2024; for the patient’s clinic visits or to indicate a phone call had been made to follow up on any needs. During a phone interview on 8/22/24 at 9:00 AM, the clinic’s Social Worker verified the above documentation that there were no notes documenting social work communication or provision of social work services in February and March 2024 and for May, June, July, and through August 22, 2024. Review on 8/22/24 at 10:48 AM of the facility policy, entitled “Social Work Services” revealed the social worker, should be available either in person or via telephone to respond to or assess/review patients’ psychosocial needs on a routine basis. Home patients should be seen either during a scheduled clinic appointment or home visit or contacted via telephone to assess psychosocial needs on a routine basis. Documentation should be made whenever there is a social work contact with the patient. Contact includes social work assessment of a patient’s psychosocial status or response to a patient request for social work assistance. Documentation should also include social work contacts to provide information, education, counseling, or intervention of any kind related to a goal on the plan of care. Documentation at appropriate intervals should demonstrate social work interventions to support the current plan of care.”