Fmc Scholls Ferry

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 37237 Based on interview, review of personnel files and review of documentation, it was determined the facility failed to ensure: 1. The facility’s emergency evacuation kit and EP binder contained updated staff contact information and patient contact and medication information. 2. Fire drills were completed according to facility policy. 3. All staff received EP training. Findings: 1. Observation of the facility on 09/23/2024 at 0930 revealed the evacuation kit lacked staff and patient contact information. - Review of the EP binder revealed both the staff contact information and patient contact and medication information were dated 09/23/2024, after the surveyors entered the facility for the recertification survey. 2. Review of fire drill documentation for Q3 2023 (July, August, September), Q4 2023 (October, November, December) and Q1 2024 (January, February, March) revealed a lack of documentation that the fire drills were completed according to facility policy. There was no documentation that the alarm system was activated and that the contracted monitoring service verified the alarm signal. - Review of the facility policy titled “Fire Drill” dated “08/02/2017,” revealed in the section titled “Fire Drills” that “In addition to the drill, activation of the fire alarm once per shift shall occur ... Verification that the fire alarm signal was received by the contracted monitoring service must occur ... Documentation of the review should be done ...” 3. Review of the “Personnel Audit Tool - ESRD” completed by the FA, revealed 2 of 12 employees (Employee #s 6 and 12) had dates of “9/23/24” and/or “9/24/24” written under “EP Disaster Training (upon hire)” and “EP Disaster Training Annual.” These dates were during the time surveyors were on-site for the recertification survey. * Employee #6 had “9/23/24” written in the column titled, “EP Disaster Training (upon hire)” and “EP Disaster Training Annual.” * Employee #12 had “9/24/24” written in the columns titled “EP Disaster Training (upon hire)” and “EP Disaster Training Annual.” The FA failed to provide documentation that the medical practitioners that visit the clinic on a regular basis to provide care to their patients had received any EP trainings. On 09/25/2024 at 1000 the FA, DO and Interim CN confirmed the above findings.”

“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: 37237 Based on observation and CDC review, it was determined that the facility failed to provide a sanitary environment to minimize the transmission of infectious agents. Findings: Observation of the treatment floor on 09/25/2024 at 1020 revealed the white prime bucket on the machine at treatment station 13 had started to accumulate a red biofilm along the inside bottom edges of the bucket. Review of the CDC document “Environmental Surface Disinfection in Dialysis Facilities: Notes for Clinical Mangers” found at: https://www.cdc.gov/dialysis-safety/media/pdfs/env-notes-508.pdf revealed: “Establish procedure for cleaning and disinfection of priming buckets. * Process should include emptying, cleaning (e.g., if blood is present), disinfection, and air-drying of bucket. * Disinfected priming buckets should be dry before reattaching to machine or use.” Failure to adequately disinfect prime buckets could lead to blood stream infections for the patients receiving hemodialysis treatments.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 47148 Based on interview and review of documentation, it was determined that the facility failed to ensure that staff members that were not immune to Hepatitis B were offered the Hepatitis B vaccination. Findings: Review of the “Personnel Audit Tool - ESRD” completed by the FA revealed that Employee #6 had “9/23/24” and Employee #12 had “9/24/24” written in the column titled, “Hepatitis B Vaccine or Decline”. These dates were after surveyors were already on site conducting this survey. During an interview with the FA on 09/25/2024 at 1000, they confirmed the findings CDC requirements incorporated by reference require all staff to be offered Hepatitis B vaccination and documentation of vaccination or declination of the vaccine be maintained. Reference can be located at http://dx.doi.org/10.15585/mmwr.rr7201a1.”

“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: 37237 Based on observations, interviews and review of documentation, it was determined that the facility failed to ensure that medications were prepared and stored correctly. Findings: Observation of the facility on 09/23/2024 beginning at 0930 revealed: - An unlabeled Ziplock bag located in a medication drawer contained 9 vials of Adrenalin, 1 vial of Solu-Cortef and 4 vials of Solu-Medrol. The 4 vials of Solu-Medrol expired on 08/31/2024. The RN on the floor at the time of observation could not explain why there was an unlabeled Ziplock of miscellaneous medication vials in the medication drawer. - An opened vial of Epogen, that lacked a date the vial had been opened or the initials of who opened it, was found in the medication refrigerator and available for use. - One box containing 10 vials and a second box containing 2 vials of “Pneumovax 23,” a pneumococcal vaccine, that expired on 08/31/2024 were available for use. - Observation of two med prep areas on 09/25/2024 beginning at 1015 revealed both med prep areas had an opened MDV of Heparin Sodium Injection 30,000 units per 30 mL in use that lacked a date the vial had been opened or the initials of who opened it. Review of the facility policy title, “Special Considerations: Epogen,” dated 02/06/2023 stipulated in the section, “Special Storage Requirements,” that “Previously punctured multi dose vials may be stored for 21 days from the date opened.” Review of facility policy titled “Medication Preparation and Administration,” dated 05/02/2022, stipulated: * “When preparing medications if the vial is not used immediately in its entirety, the nurse or PCT (if allowed by state regulations), must place the date and time the vial was opened on the medication label along with their initials. Note: 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.” * “Label any open multi-dose vial that is not used immediately and store vial accordingly.” * “Expiration dates for all stored medications are to be monitored on a monthly basis. Expired medications are to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state law. Any open multi dose vials must be discarded 28 days after opening or per manufacturer’s expiration date.” During interview with the DO and Interim CN on 09/23/2024 at approximately 1330 and on 09/25/2024 at 1215, the above findings were confirmed.”

“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: 37237 Based on observation and review of documentation, it was determined the facility failed to ensure that personnel responsible for performing the chlorine test completed the test according to the facility’s procedure. Findings: Observation of the total chlorine test on 09/25/2024 at 1055 with an RN and Patient Care Technician (PCT) revealed the PCT collected a 100-milliliter (ml) water from the chlorine sample test port. The PCT moved the test strip backward and forward for the required time but then removed the test strip and immediately held the test strip up to the color chart to compare the colors. The PCT failed to shake the test strip once to remove the excess water and failed to wait 20 seconds for the test strip to develop before comparing the test strip to the color chart. The RN that accompanied the PCT for the total chlorine test failed to correct the PCT’s mistakes and verified the PCT’s color comparison. Review of the facility policy, “Total Chlorine Testing using RPC Ultra Low Total Chlorine Test Strips Procedure,” dated 04/05/2021 stipulated: * “Step 4 ... Remove the strip and shake once, briskly, to remove excess water.” * “Step 5 ... Wait 20 seconds for the test strip color to develop ...” * “Step 6 ... After the 20 second wait period, immediately compare the strip color to the K100-0118F color chart to determine the Total Chlorine level in the sample.””

“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: 37237 Based on observation, it was determined the facility failed to ensure that all equipment was maintained and operated in accordance with the manufacture’s recommendations. Findings: Observation of the facility on 09/23/2024 beginning at 0930 revealed the “Minnicare HD Residual Test Strips” container in use in the water room expired on 09/22/2024. The six containers of the residual test strips available for use in the storage room also expired on 09/22/2024.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 47148 Based on observation and interview, it was determined the facility failed to prominently display a notice that included the correct State Agency complaint contact information that could be easily seen and read by patients. Findings: Observation of the facility’s lobby on 09/23/2024 revealed the document “Fresenius Kidney Care Important Numbers” available for patients to review. Review of the document revealed “Your concern is important to us. If you feel we are not doing our part ... please use the following important numbers to report the issue. All reports are treated as confidential and we will work to handle your concerns quickly.” The document contained the contact information for the Facility Administrator, the Director of Operations and the Regional Vice President. The document also contained, “You may also Contact,” information for the ESRD Network and for the State Agency. The State Agency contact information listed an incorrect address located in the wrong city. The DO and Interim CN confirmed the above findings on 09/25/2024 at 1200.”

“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: 47148 Based on interview, review of patient medical records and review of documentation, it was determined that for 5 of 6 patients (Patient #s 1, 2, 4, 5 and 6) the facility failed to ensure that patients: * Received appropriate and timely nursing assessments before and after hemodialysis treatment. * Appropriate and timely safety checks. * Treatment medications were administered per hemodialysis order. * A BFR/DFR rate per hemodialysis order. Findings: Patient #1 Review of Patient #1’s treatment flowsheets dated 08/26/2024 through 09/23/2024 reflected the following: - On 09/23/2024 the treatment flowsheet reflected a VS and access check at 0631. The next check was 49 minutes later at 0720. * The treatment flowsheet reflected the hemodialysis order included “BFR: 400.” At 0514, treatment was initiated and the BFR was set at 350. At 0602 the BFR was lowered to 300 with no documentation to show the RN was notified or the RN followed-up to evaluate whether the order was not followed as prescribed. - On 09/20/2024 the treatment flowsheet reflected treatment was initiated at 0514. At 0531, the BFR was set at 375 and then lowered to 350 at 0704 where it remained until treatment was terminated at 0914 with no documentation to show the RN was notified or the RN followed-up to evaluate whether the order was not followed as prescribed. * At 0602, the patient’s BP was recorded as 103/62 mmHg and the HR was recorded as 63 bpm. At 0833 the BP was recorded as 108/73 mmHg and the HR was 81 bpm. In the “Special Attentions” section of the flowsheet, there was an order written for “Give 10mg midodrine is [sic] SPB drops below 115.” And “Midodrine 10mg for sbp<115 if HR >48 per PA...” The flowsheet lacked documentation that midodrine was administrated to the patient during treatment. - Similar findings were identified on treatment flowsheets dated 08/30/2024, 09/04/2024, 09/06/2024, 09/11/2024, 09/13/2024 and 09/18/2024. Patient #2 Review of Patient #1’s treatment flowsheets dated 08/23/2024 through 09/20/2024 reflected the following: - On 09/18/2024 the treatment flowsheet reflected treatment was initiated at 1136. At 1233, the patient’s BP was recorded as 88/50 mmHg. The PCT documented “b/p hypotensive, pt states [the patient] feels fine, b/p every 15.” The next VS reading was taken 34 minutes later at 1307. No 15 minute BP checks were recorded. The patient’s systolic BP remained < 120 mmHg until 1439. * Similar findings were identified on treatment flowsheets dated 09/20/2024. Patient #4 Review of Patient #4’s treatment flowsheets dated 08/26/2024 through 09/17/2024 reflected the following: - On 08/28/2024, the treatment flowsheet reflected a PCT documented treatment was initiated at 0632. The treatment flowsheet revealed a “Nursing Evaluation” completed by an RN at 0722. At 1033, a PCT documented the treatment had ended and the flowsheet lacked a post-treatment nursing assessment. * Similar findings on treatment flowsheets dated 09/05/2024, 09/07/2024 and 09/10/2024. Patient #5 Review of Patient #5’s treatment flowsheets dated 08/15/2024 through 09/06/2024 reflected the following: - On 08/15/2024, the treatment flowsheet reflected the hemodialysis order included “DFR: Manual 800 mL/min.” At 1108, treatment was initiated and the PCT documented a DFR of “500” where it remained for the remainder of the treatment with no documentation to show the RN was notified or the RN followed-up to evaluate whether the order was not followed as prescribed. * Similar findings on treatment sheet dated 08/16/2024. - On 08/15/2024, the treatment flowsheet reflected a PCT documented treatment was initiated at 1108. At 1511, a PCT documented the treatment had ended. The treatment flowsheet revealed one “Nursing Evaluation” completed by an RN at “1534.” It is not discernable whether it is a pre-treatment or post-treatment nursing assessment. * Similar findings on treatment flowsheet dated 09/06/2024. Patient #6 Review of Patient #6’s treatment flowsheets dated 08/22/2024 through 09/20/2024 and hemodialysis orders with a start date of 03/24/2024 reflected the following: - The “Orders Summary Report” printed on 09/24/2024 reflected an order for “Heparin Sodium 1000 Units/mL ... Infusion (Pump) 500 units IVP per hour. turn pump off 60 minutes prior to the end of treatment. Every Treatment.” - On 08/22/2024, the treatment flowsheet reflected lack of documentation that the prescribed Heparin was administered during treatment. - On 08/27/2024, the treatment flowsheet reflected that at 1534, a PCT documented “Treatment discontinued without problem” and the Heparin “Stop Date/Time” at “08/27/2024 1517.” Documentation failed to reflect a reason the treatment was not given as prescribed. - On 09/06/2024, the treatment flowsheet reflected a PCT documented treatment was initiated at 1320. At 1703, a PCT documented the treatment had ended. The treatment flowsheet revealed one “Nursing Evaluation” completed by an RN at 1720. Based on the time documented, this was the post-treatment nursing assessment and the flowsheet lacked documentation of a pre-treatment nursing assessment. - On 09/11/2024, the treatment flowsheet reflected a PCT documented treatment was initiated at 1328. At 1711, a PCT documented the treatment had ended. The treatment flowsheet revealed one “Nursing Evaluation” completed by an RN at 1453. Based on the time documented, this was the pre-treatment nursing assessment and the flowsheet lacked documentation of a post-treatment nursing assessment. Review of facility policy titled,”Patient Assessment and Monitoring,” dated 05/01/2023, stipulated: - “Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow ... Check dialysate flow rate setting is correct, and the prescribed flow is being delivered.” - “If heparin pump is used, ensure heparin is infusing at prescribed rate.” - “The Registered Nurse will assess/re-assess any findings addressed pre or during treatment ... The registered nurse will assess/re-assess post treatment ...” Review of the facility RN job description titled, “OUTPATIENT RN CAP 1” dated 11/2/2023, stipulated one of the RN’s “Principal Duties and Responsibilities” as “Performs ongoing, systematic collection and analysis of patient data pre - during - post hemodialysis treatment for assigned patients and documents in the patient medical record ....” During an interview with the FA on 09/25/2024 at 1200 the above findings were confirmed.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 47148 Based on interview and review of documentation, it was determined that the facility failed to offer pneumococcal vaccination to patients based on assessment of status as required by facility policy and CDC guidelines for 9 of 61 patients (Patient #s 7-15). Findings: Review of the “Pneumonia Vaccination Report,” printed on 09/23/2024 revealed 8 of 61 patients had “09/23/2024” entered in the “Next Due Date” column. The “Suggested Action(s)” column for all 8 patients advised administration of the appropriate pneumococcal vaccine product specific to each patient based upon age and current vaccination status per facility policy. Documentation failed to reflect that the vaccination had been offered to those patients. Examples include but are not limited to: * Patient #9 had documentation of receiving PPSV23 on 11/04/2015. No other documentation as to subsequent pneumococcal vaccine given, offered or refused was noted. * Patient #13, with an admit date of 07/17/2024, had no documentation of having received any pneumococcal vaccine since admitted to the facility. Similar findings for Patient #s 8, 10-12, 14 and 15. Further review of the “Pneumonia Vaccination Report” revealed Patient #7, had “Vaccination Administered Elsewhere 04/27/24 Unknown” in the “Immunization Tracking” column. The “Suggested Action(s)” column indicated “Consult with physician for vaccination orders”. Review of the facility policy titled, “Pneumococcal Vaccine for Adults,” dated “02/05/2024 Version: 6” stipulated, “Patients should receive vaccines based on the administration frequencies outlined below.” The policy provided guidelines for offering pneumococcal vaccines to patients based on age and vaccination history as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices in September 2023. During interview with the FA on 09/23/2024 at 1530, the above findings were presented. The FA agreed that the system that generated this report defaulted to the current date under “Next Due Date” when a suggested action is overdue and confirmed the above findings.”

“PQ-H20 TREATMENT SYSTEM TECHS TRAINING CFR(s): 494.140(f) Technicians who perform monitoring and testing of the water treatment system must complete a training program that has been approved by the medical director and the governing body. This Standard is not met as evidenced by: 47148 Based on interview and review of documentation, the facility failed to ensure that all staff members who operates the water treatment system complete a training program prior to independently performing water treatment system tasks. Review of the “Personnel Audit Tool - ESRD” completed by the FA revealed Employee #2, identified as an RN, had “9/24/24” written in the column titled, “H20 Dialysate Training”. Review of the electronic water treatment system records dated March 2024 through September 2024, Employee #2 was documented as performing various water treatment system tasks prior to 09/24/2024. Examples include, but not limited to: * The “Post Worker Carbon Tank - TCL - 1” log dated “03/02/2024” revealed that Employee #2 conducted the test at 1439 and 1805. * The “Post Worker Carbon Tank - TCL - 1” log dated “04/30/2024” revealed that Employee #2 conducted the test at 1436 and 1836. * The “Post Worker Carbon Tank - TCL - 1” log dated “05/11/2024” revealed that Employee #2 conducted the test at 1436 and 1806. Review of the facility policy titled, “Carbon Filtration Monitoring for Incenter Center Water Systems” dated “11/07/2022” version 9 stipulated, “Training Requirements ... FKC staff monitoring carbon filter performance must have documented evidence of ... Completion of annual water training.” Further review revealed, “Verification of Test Results ... Two trained staff members, one of whom must be a licensed RN, will perform and verify total chlorine testing.” During an interview with the FA on 09/25/2024 at 1000, the above findings were confirmed.”