Fresenius Medical Care Derby

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 38800 Based on interview and document review the End Stage Renal Dialysis (ESRD) facility failed to maintain accurately documented annual patient emergency training. This deficient practice has the potential to place patients at risk for harm or injury during an emergency situation. Findings Include: Document review on 12/10/24 between 1:00 PM and 3:00 PM showed that patient signatures were not present on the annual emergency training documents. During an interview on 12/10/24 at 3:00 PM, the Director of Operations confirmed that patients sign the orientation emergency training but do not sign the annual emergency training documents. Staff acknowledged findings.”

“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: 43397 Based on observation, policy review, and interview, the facility failed to ensure 2 of 2 Certified Clinical Hemodialysis Technicians (CCHTs) (Staff E and F) performed hand hygiene before they touched patient care equipment and before patient contact. Failure to perform hand hygiene provided a mode of cross contamination with the potential spread of pathogens, which could negatively impact the health and well-being of the 28 patients who received dialysis treatments at the facility. Findings Include: Review of a policy titled, “Hand Hygiene,” dated 11/06/23, showed that washing hands with soap and water or the use of hand sanitizer is required “Before and after direct contact with patients ...Immediately after removing gloves ...After contact with inanimate objects near the patient ...” An observation on 12/09/24 at 12:30 PM, showed Staff E, Certified Clinical Hemodialysis Technician (CCHT) touched the dialysis machine at Station 12 with gloved hands then left Station 12 and touched the dialysis machine at Station 11. Staff E failed to change gloves and perform hand hygiene between dialysis stations and after touching inanimate objects as required per facility policy. During an interview on 12/09/24 at 2:25 PM, Staff E, CCHT, acknowledged that she failed to change gloves and perform hand hygiene between Station 4 and 5 and stated, “I knew what I did as soon as I did it.” Staff E confirmed that she received infection control training and is expected to perform glove changes and hand hygiene between patients or dialysis stations. An observation on 12/11/24 at 8:38 AM, showed Staff F, CCHT, touched the dialysis machine and bloodlines at Station 5 with gloved hands then removed the dialysis needles from the patient’s arm without changing gloves and performing hand hygiene. During an interview on 12/11/24 at 9:20 AM, Staff F, CCHT stated, “I should have changed gloves after touching the machine and before pulling the patient’s needle.” During an interview on 12/10/24 at 4:38 PM, Staff B, Registered Nurse (RN), stated that failure to perform hand hygiene before/after glove use and between patient contact increases patient risk of potential serious infections. During an interview on 12/10/24 at 10:35 AM, Staff A, Director of Operations, stated the expectation is that staff follow facility policy for hand hygiene and confirmed that failure to do so increases risk of infection and patient mortality. During an interview on 12/11/24 at 7:30 AM, Staff D, Medical Director, stated that not performing hand hygiene is unacceptable and staff are expected to follow policy. Staff D confirmed that failure to perform hand hygiene increases patient risk for infection.”

“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: 43397 Based on observation, policy review, and interview, the facility failed to ensure staff disinfected all dialysis equipment and other surfaces that could be potentially contaminated with patient’s blood after a dialysis treatment. Failure to ensure all surfaces of the dialysis machine or other objects that could come in contact with a patient are appropriately disinfected, provided a mode of potential transmission of bloodborne pathogens, which could negatively impact the health and well-being of the 28 patients who received dialysis treatments at the facility. Findings Include: Review of a policy titled, “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/23, showed, “The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 (ratio of bleach to water) bleach or EPA (Environmental Protection Agency) registered disinfectant ...Externally disinfect the dialysis machine with 1:100 bleach solution after each dialysis treatment ...All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures ...) An observation of the treatment area on 12/11/24 at 9:20 AM, showed Staff F, Certified Clinical Hemodialysis Technician (CCHT) failed to disinfect the IV pole of the dialysis machine, the extendable TV/arm, and emergency take off kit at Station 5 as required per facility policy. During an interview on 12/11/24 at 9:20 AM, Staff F, CCHT, confirmed that she did not disinfect the IV pole of the dialysis machine nor the TV/arm, and emergency take off kit with 1:100 bleach disinfectant as required per policy and stated that failure to do so could increase the risk of patient infection. During an interview on 12/11/24 at 7:30 AM, Staff D, Medical Director stated that failing to follow infection control policies is unacceptable and increases patient risk for infection.”

“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: 43397 Based on observation, policy review, and interview, the facility failed to ensure that medications were properly stored and labeled to prevent contamination, medication error, or administration of incorrect and/or expired medication as required per facility policy. The failure to adhere to facility medication administration policy provided an opportunity for a contaminated medication, incorrect medication, or expired medication to be administered to a patient, which could negatively impact the health and well-being of the 28 patients who received dialysis treatments at the facility. Findings Include: Review of a facility policy titled, “Medication Preparation and Administration,” dated 02/06/23, showed that oral medications that are not administered immediately must be labeled, “ ...with the name of the medication, route, dose, name of patient, date, time and initials of the person who prepared the medication ...” and that medication vials must be labeled, “ ...must place the date and time the vial was opened on the medication label along with their initials. 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 ...” An observation of the medication station on 12/09/24 at 11:18 AM, showed two opened multi-dose vials of medication without an opened date, time, and/or date of expiration. An uncovered dose cup of an oral liquid medication was also noted without an identifying label to show type of medication, dose, route, patient, date, time, and initials of the person who prepared the medication. During an interview on 12/09/24 at 11:18 AM, Staff B, Clinic Manager, confirmed the medication findings and stated it was against facility policy to open a medication vial without labeling it with a date and time, and it was against policy to store a prepared medication without an identifying label. Staff B confirmed that the uncovered liquid medication was at risk for contamination from improper storage and that failure to follow medication administration policy placed patients at risk of having a medication error that could result in patient harm. During an interview on 12/11/24 at 7:30 AM, Staff D, Medical Director stated that it is an expectation of nursing staff to appropriately label and date medications to prevent administration of expired medications or administering a wrong medication to a patient that could result in an adverse patient occurrence.”

“RO-CHEMICAL ANALYSIS-FREQUENCY CFR(s): 494.40(a) 6.2.7 Reverse osmosis: Chemical analysis: frequency Chemical analysis for the contaminants listed in 4.1.1 (Table 1) should be done when the RO system is installed, when membranes are replaced, and at not less than annual intervals thereafter to ensure that the limits specified in 4.1.1 are met (see Table 1). Chemical analyses should be done when seasonal variations in source water suggest worsening quality or when rejection rates fall below 90 %. This Standard is not met as evidenced by: 43397 Based on document review, policy review, and interview, the facility failed to ensure that chemical analysis testing for dialysis water contaminants was completed at intervals not less than annually. Failure to complete chemical analysis testing at required intervals poses a risk of dialysis water contaminants going undetected which could negatively impact the health and well-being of the 28 patients who received dialysis treatments at the facility. Findings Include: Review of a policy titled, “AAMI (Association for the Advancement of Medical Instrumentation) Chemical Analysis of Water for Dialysis” dated 11/04/24, showed, “An AAMI Chemical Analysis will be collected and sent to Spectra Laboratories for testing at a minimum of Quarterly ...Samples will be collected and sent in accordance with Spectra Laboratories documents “Collection Instructions: Water Testing for Chemical Contaminants” and “Shipping Instructions: AAMI Water Testing for Chemical Contaminants ...” The policy also showed that biomedical staff are to review test results at a minimum of quarterly (every three months) to compare sample results with previous results to determine trends and to ensure samples have been collected, interpreted, and action taken in accordance with the policy. Review of a Spectra Laboratories document titled, “Collection and Shipping Guide Water Testing for Chemical Contaminants,” published 2023, showed the process for obtaining and shipping samples included the following: Place an order for the sample; Print barcode label for the sample; Affix the barcode to the bottle for which the sample is being collected; Place the bottle in the AAMI shipping box and include paper requisition; Ship the sample via UPS (United Parcel Service) or FedEx. Review of facility report titled, “AAMI Summary by Date,” dated 01/01/23 to 12/10/24, showed AAMI water testing results for chemical contaminants dated 04/27/23. The facility was unable to provide documented evidence of testing from 04/27/23 to 12/10/24. During an interview on 12/10/23 at 10:35 AM, Staff A, Director of Operations, stated the facility had not obtained quarterly AAMI water quality analysis results since April 2023. She stated the biomedical technician had drawn the specimens but failed to apply a label to the specimen container and failed to include the order/requisition in the shipping box, therefore testing was not able to be completed by the lab. Staff A stated the lab informed her that any samples without an order or specimen label would be thrown away upon receipt due to the inability to determine what type of testing was needed. Staff A confirmed that AAMI water quality analysis testing is required quarterly per facility policy and the failure to ensure testing is completed and monitored put patients at risk for an adverse event potentially causing harm. During an interview on 12/11/23 at 7:30 AM, Staff D, Medical Director, stated her expectation was that facility staff be properly trained, knowledgeable, and competent in proper water testing procedures. She stated that missed AAMI water quality analysis testing could potentially put patients at risk for harm.”

“PR-INFORMED OF PT CARE POLICIES CFR(s): 494.70(a)(8) The patient has the right to- (8) Be informed of facility policies regarding patient care, including, but not limited to, isolation of patients; This Standard is not met as evidenced by: 43397 Based on medical record review, policy review, and interview, the facility failed to ensure 1 of 5 sampled patients (Patient 5) was informed of facility policy/procedure for discontinuation of dialysis and evacuation in case of emergency procedures. The failure of the facility to provide policy/procedures for disconnection and evacuation during an emergency has the potential to negatively impact the health and well-being of the 28 patients who received dialysis treatments at the facility. Findings Include: Review of a policy titled, “Guidelines for Emergency Preparedness,” dated 07/03/23, showed, “ ...Facility staff must educate patients on: Evacuation procedures; Emergency Disconnection Procedures; Emergency Meal Plan; Facility Contact Information; Shelter Information; Transportation Information; Emergency Preparedness ...” Review of patient 5’s medical record failed to show documented evidence that Patient 5 was provided with information of the facility’s emergency preparedness policies or procedures that could be verified by patient signature of receipt and understanding. Upon request, the facility was unable to provide documentation signed by the patient acknowledging receipt of same. During an interview on 12/09/24 at 12:15 PM, Patient 5 stated that she was not aware of the facility’s procedure for emergency disconnection and evacuation procedures. Patient 5 stated that she had not received facility policy or procedures upon admission nor education on emergency preparedness policies and procedures. During an interview on 12/10/24 at 8:36 AM, Staff B, Clinical Manager stated the facility was unable to locate documentation signed by Patient 5 to verify the patient was provided with education on emergency take off procedures. Staff B stated that failure to provide education on emergency procedures to patients could potentially place patients at risk for delayed evacuation in case of an emergency and possible harm. During an interview on 12/11/24 at 7:30 AM, Staff D, Medical Director stated it is the expectation that all patients receive information and ongoing education on emergency preparedness training, including emergency take off and evacuation procedures. Staff D stated failure to provide such information could potentially complicate an emergency evacuation situation and lead to patient injury or harm.”

“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: 43397 Based on policy review, record review, and interview, the facility failed to follow the individualized dialysis prescription as prescribed by the medical provider for 4 of 4 sampled patients (Patient 1, 2, 3 and 4). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the 29 patients who received dialysis treatments at the facility. Findings Include: Review of a policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, showed that staff must ensure the blood flow rate (BFR) and dialysate flow rate (DFR) is being achieved or reason is documented in the medical record if unable to meet prescribe flow rate. Patient 1 Review of Patient 1’s medical record showed a prescribed BFR of 450 milliliters per minute (mL/min) and a DFR of Auto 1.5 (a rate of the prescribed BFR multiplied by 1.5) which would equal approximately 650-700 mL/min. Review of 6 consecutive treatment records for Patient 1 dated 11/27/24 to 12/09/24 showed the following: On 12/02/24 at 10:03 AM, the BFR was documented at 300 mL/min. There was no rationale documented why the prescribed BFR was not achieved. On 12/06/24 at 10:03 AM, 11:34 AM, and 12:04 PM, the BFR was documented at 425 mL/min. The DFR was documented at 800 mL/min for the entire treatment. There was no rationale documented why the prescribed BFR and DFR were not achieved. Patient 2 Review of Patient 2’s medical record showed a prescribed BFR of 400 mL/min and a prescribed DFR of 600 mL/min. Review of 6 consecutive treatment records for Patient 2 dated 11/25/24 to 12/06/24 showed the following: On 11/25/24 at 11:18 AM the DFR was documented at 800 mL/min for the entire treatment. There was no rationale documented why the prescribed DFR was not achieved. On 11/27/24 at 2:33 PM the BFR was documented at 350 mL/min. There was no rationale documented why the prescribed BFR was not achieved. On 11/29/24 at 12:05 PM the DFR was documented at 800 mL/min for the entire treatment. There was no rationale documented why the prescribed DFR was not achieved. On 12/02/24 at 12:07 PM the BFR was documented at 400 mL/min until end of treatment. There was no rationale documented why the prescribed BFR was not achieved. On 12/04/24 at 11:18 am the DFR was documented at 800 mL/min. At 11:45 to 12:00 PM the BFR was documented at 300 mL/min. At 12:30 PM the DFR was documented at 350 mL/min until end of treatment. There was no rationale documented why the prescribed BFR and DFR were not achieved. Patient 3 Review of Patient 3’s medical record showed a prescribed BFR of 450 mL/min and a prescribed DFR of Auto 1.5 (a rate of the prescribed BFR multiplied by 1.5) which would equal approximately 650-700 mL/min. Review of 6 consecutive treatment records for Patient 3 dated 11/15/24 to 12/02/24 showed the following: On 11/22/24 at 11:15 AM the BFR was documented at 400 mL/min and the DFR was documented at 800 mL/min. At 11:34 AM the BFR was documented at 400 mL/min until end of treatment and DFR was documented at 600 mL/min until the end of treatment. There was no rationale documented why the prescribed BFR and DFR were not achieved. On 11/25/24 at 1:01 PM the BFR was documented at 425 mL/min. At 1:33 PM the BFR was documented at 400 mL/min until end of treatment and DFR was documented at 600 mL/min until the end of treatment. There was no rationale documented why the prescribed BFR and DFR were not achieved. On 11/29/24 at 12:01 PM the BFR was documented at 400 mL/min until end of treatment and DFR was documented at 600 until the end of treatment. There was no rationale documented why the prescribed BFR and DFR were not achieved. Patient 4 Review of Patient 4’s medical record showed a prescribed BFR of 350 ml/min. Review of 6 consecutive treatment records for Patient 4 dated 11/25/24 to 12/06/24 showed the following: On 11/25/24 at 2:05 PM the BFR was documented at 300 mL/min until the end of treatment. There was no rationale documented why the prescribed BFR was not achieved. During an interview on 12/10/24 at 4:38 PM, Staff B, Clinical Manager, stated failure to follow the physicians’ prescribed treatment order for BFR and DFR could result in inadequate dialysis and poor clinical outcomes. During an interview on 12/11/24 at 7:30 AM, Staff D, Medical Director, stated failure to follow dialysis prescription increased the risk of too much or too little dialysis and could result in poor clinical outcomes.”