Davita NE Salem Dialysis

“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. All staff received training in the use of emergency procedures. 2. All staff received annual EP training. Findings: Documentation included a completed personnel audit worksheet for 13 full-time staff, presented by the FA on 01/23/2025. The worksheet revealed gaps in the required personnel documentation. Examples included, but were not limited to: - 3 of 13 staff (Staff #s 2, 3, 12) had documentation of “Emergency Procedures” on 01/21/2025 after the surveyors were on-site for the recertification survey. - 1 of 13 staff (Staff # 13) had documentation of annual “EP Training” on 01/21/2025 after the surveyors were on-site for the recertification survey. During review of the facility policy titled, “Facility Emergency Management Plan” dated, “April 2024” stipulated, “The FA, or designee, is responsible to provide training of EMP ... i. Annually ... Policy Facility Emergency Management Plan ... Facility specific emergency response procedures ... III ... Upon Hire ... v. Document training in teammate file.” During an interview with the FA and MCS on 01/23/2025 at approximately 1530 the above findings were confirmed.”

“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: 31224 37237 Based on observation and interview, it was determined that the facility failed to ensure a sanitary environment to minimize the transmission of infectious agents within the facility and other public areas. Findings: Observation of the facility on 01/21/2025 beginning at 1025 revealed: - The drain by the door in the water treatment room was covered with significant buildup and did not reflect regular cleaning. The metal grate to the drain was covered with a black substance. The laminate area surrounding the grate was discolored by a biofilm and surrounded by the black substance. - The white plastic sides of the drain along the far wall of the water treatment room had a red biofilm growing on all 4 sides. The drain area had a significant amount of a black substance on the plastic sides of the drain, the wall and on a metal frame that surrounded the drain. - The floor, wall and white pipes at the back of the water treatment room with the RO and carbon tanks had an accumulation of a black substance on their surfaces. - There was a yellow/green stain on the floor under the expansion tank. - There was an accumulation of white precipitate on the floor around and on top of the boost pump. - Numerous bags of Morton Water Softener Pellets were stored on the floor of the water treatment room (not on a pallet) next to the boost pump and expansion tank. - There was an accumulation of water on the floor under the sink labeled “Sanitary Drain for discharge of neutralized residual acid concentrate.” - The eyewash station in the water treatment room had a small amount of accumulated debris in the nozzles. - The upholstery of one of the chairs at the RN station was flaking off and could not be effectively cleaned for infection control purposes. - Treatment chairs #7 and #12 had rips in the upholstery that exposed the foam underneath and could not be cleaned effectively for infection control purposes. - The sink cabinet in the biohazard room was missing one of the laminated panels that exposed the raw wood underneath. - Multiple area of the lobby and treatment floor area had areas of chipped paint that exposed the drywall underneath and could not be cleaned effectively for infection control purposes. - There was tape and sticky tape residue on cabinets and doors throughout the facility. - Areas of the white laminate flooring with cracks had a black substance that accumulated in and around the cracks. - An oxygen concentrator on the treatment floor was found stored underneath a handwashing sink and paper towel dispenser with water drips on it. The FA and MCS confirmed the above findings on 01/23/2025 at 1530.”

“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: 37237 Based on observation and review of documentation, it was determined the facility failed to ensure that gloves were changed and hands were washed between each patient contact and/or between patient stations. Findings: Observation of the treatment floor on 01/23/2025 beginning at 1330 revealed: - At 1330 a staff member that was discontinuing treatment for a patient with CVC picked up a biohazard bin to move closer to the patient. The staff member had on gloves but failed to remove the gloves prior to or after they picked up the biohazard bin then proceeded to clean a CVC hub. * At 1400, the same staff member repeated the above on a different patient. - A PCT was observed leaving a patient area, picking up a supply item and then entering another patient area all without performing hand hygiene. - A PCT staff member failed to perform hand hygiene after removing gloves and prior to re-gloving. Review of facility policy 1-05-01 “Infection Control for Dialysis Facilities,” dated as last revised “April 2023” stipulated * “1. All teammates, Physician and Non-Physician [Practitioner] (NPP) will perform hand hygiene ... upon entering and exiting the patient treatment area ... prior to gloving and immediately after removal of gloves ... after contamination with blood or other infectious material ... between patients even if the contact is casual ... before touching clean areas such as supplies, supply cart and chairside keyboard/mouse ...” * “7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station ... ii. When going from a ‘dirty’ area or task to a ‘clean area or task...””

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 37237 Based on observation and interview, it was determined that the facility failed to ensure that warm water was available at all of the sinks. Findings: Observation of the facility on 01/21/2025 beginning at 1025 revealed all the sinks in the facility failed have warm water. Every sink that was tested, the water remained cold even after running up to 30 seconds. On 01/21/2025 at 1435, the FA confirmed the water in all the sinks was cold and did not warm up. They stated the water heater had been replaced the previous week and did not fix the problem.”

“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: 31224 Based on interview and review of documentation, it was determined the facility failed to ensure that all susceptible patients and staff were offered vaccination against Hepatitis B. Findings: Review of the facility’s “Vaccinations and Surveillance Report,” dated 01/21/2025, revealed 5 of 65 patients (Patient #s 2, 9, 23, 31 and 33) were susceptible to Hepatitis B, but had not been provided the full vaccine series, were not offered a second vaccine series, or offered a booster vaccine. For example: * Patient #2 completed one full series of the Hepatitis B vaccine on 07/29/2024. The next HBsAB lab was not taken until 01/20/2025 and resulted in a value of less than 10 mIU/mL and meant Patient #2 did not have sustained immunity to Hepatitis B. The late lab led to Patient #2 not being identified as needing or being offered a second series of the Hepatitis B vaccine in a timely manner. * Patient #9 received the first dose of the Hepatitis B vaccine on 11/25/2024. No subsequent doses were documented as of the 01/21/2025 report. * Patient #23 received two full series of the Hepatitis B vaccine and was immune. The most recent HBsAb lab taken on 08/26/2024 resulted in a value of less than 10 mIU/mL and Patient #23 was again susceptible to Hepatitis B. There was no documentation to show a booster dose of the vaccine was offered. Similar findings were noted for Patient #s 31 and 33. Review of facility policy titled “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance”, dated as last revised “April 2024,” stipulated: * “Test all vaccinated patients for HBsAb one (1) to two (2) months after the last dose of the full vaccine series (adequate response is defined as greater than or equal ... 10 mIU/mL.) a. If hepatitis B surface antibody (HBsAB) is less than ... 10 mIU/mL, consider the patient susceptible, revaccinate with an additional full series, and retest for HBsAb one(1) to two (2 months after the last dose of the second series... c. On annual retesting of immune patients due to vaccination, HBsAb less than ... 10 mIU/mL, with nephrologist order, administer a booster dose of vaccine.” During interview on 01/23/2025 at 1100, the CN confirmed the above findings.”

“IC-HBV-TEST PTS/STAFF POST LAST DOSE CFR(s): 494.30(a)(1)(i) Hepatitis B Screening: Patients and Staff Test all vaccines [patients and staff] for anti-HBs 1-2 months after last primary vaccine dose. -- If anti-HBs is <10 mIU/mL, consider patient or staff member susceptible, revaccinate with an additional three doses, and retest for anti-HBs. -- If anti-HBs are =10 mIU/mL, consider immune, and retest patients annually. -- Give booster dose of vaccine to patients if anti-HBs declines to <10 mIU/mL and continue to retest patients annually. This Standard is not met as evidenced by: 31224 Based on interview, review of documentation and patient clinical record review for 8 of 65 patients (Patient #s 16, 21, 26, 28, 32, 43, 59, and 62), it was determined the facility failed to test all patients for anti-HBs 1-2 months after the last primary vaccine dose. Findings: Review of the facility’s “Vaccinations and Surveillance Report,” dated 01/21/2025, revealed seven patients had completed the Hepatitis B vaccine series, but were not tested to assess whether they had immunity. For example: * Patient #16 received the last dose of the Hep B vaccine on 09/27/2024, however there was no HBsAb lab result documented after that date. * Patient #21 received the last dose of the Hep B vaccine on 10/18/2024, however there was no HBsAb lab result documented after that date. * Patient #26 received the last dose of the Hep B vaccine on 09/24/2024, however there was no HBsAb lab result documented after that date. Similar findings were noted for Patient #s 28, 32, 43, 59 and 62. Review of facility policy titled “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance”, dated as last revised “April 2024,” stipulated, “Test all vaccinated patients for HBsAb one (1) to two (2) months after the last dose of the full vaccine series (adequate response is defined as greater than or equal to 10 mIU/mL.” During interview on 01/23/2025 at 1100, the CN confirmed the above findings.”

“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 observation, interview and review of documentation, it was determined that the facility failed to ensure that medications were prepared and stored correctly. Findings: Observation of the treatment floor on 01/21/2025 beginning at 1025 revealed: - A Heparin syringe with a preprinted patient label dated 01/21/2025 and initialed lacked the time the medication was prepared. - An opened MDV of Heparin had a label with “Opened: 1-21-25” and “Exp: 1-19-25” handwritten on the label. - An opened MDV of Lidocaine lacked a BUD label. Observation of the treatment floor on 01/23/2025 at 1315 revealed: - An opened MDV of Heparin lacked a BUD label. - Two opened MDVs of Lidocaine had a label with “Opened 1/22/25” and “Exp 2/10/25.” Of the three opened and labeled MDVs, none were labeled correctly. One was labeled with the expiration date prior to the opened date, and two were labeled to be discarded only 19 days after the vials were opened. Review of facility policy 1-06-01 titled, “Medication Policy,” dated as last revised “October 2023” stipulated: - “20. If medications are prepared and administered immediately, by the same licensed nurse teammate, the medications do not need to be labeled. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initial of teammate preparing the medication.” - “29. Medications containing a preservative must be discarded 28 days after opening or accessed (e.g. needle punctured), unless the manufacturer species a different (shorter or longer) date or as directed by the manufacturer as in the case of vaccines or state specific pharmacy regulation. Each vial is labeled with the initials of the person opening the vial and the expiration date ...” During an interview with the FA and MCS on 01/23/2025 at approximately 1530 the above findings were confirmed.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 37237 Based on interview and observation, it was determined that the water purification and storage system was not secured or restricted to prevent access by unauthorized users. Findings: Observation of the facility on 01/21/2025 beginning at 1025 revealed the water purification system was located within a supply room. The supply area had an entrance door off the treatment floor that was accessible with a keyless entry lock which utilized a security door code. The door code to the supply area was the same code for all other secured areas. Entrance into the water treatment room was secured with a combination lock. The combination lock was found opened, giving easy access to the water treatment room. During interview with the FA and MCS on 01/21/2025 at approximately 1430, the above observation was confirmed.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 37237 Based on interview, review of personnel records and review of documentation, it was determined that the facility failed to ensure that 6 of 10 clinical staff (Staff #s 3 - 7 and 9) responsible for operating, testing and monitoring the water and dialysate systems completed the required training and annual skills checks required by the facility policy and this regulation. Findings: Review of the personnel file worksheet presented on 01/23/2025 revealed: - Six staff members (Staff #s 3, 4, 5, 6, 7 and 9) were listed as having completed “H2O Dialysate Training” on 01/21/2025 while the surveyors were on-site for the recertification survey. Review of facility policy 8-02-08 titled, “Auditing of Clinical Practice Requirements for Water and Dialysate Concentrate,” dated as last revised “April 2021” stipulated “The ESRD Conditions for Coverage require the operators of the water/dialysate system equipment to be trained by the manufacturer of the equipment or the training must be done form materials provided by the manufactures. Initial training will be completed after new hire an annually thereafter.” During an interview with the FA and MCS on 01/23/2025 at approximately 1530 the above findings were confirmed.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 31224 Based on observation and interview, it was determined the facility failed to ensure the building was maintained to ensure the safety of patients, staff and the public. Findings: Observation of the facility on 01/21/2024 starting at 1025 revealed the patient restroom on the treatment floor was missing the pull cord to activate the emergency call light. On 01/21/2025 at 1435, the FA confirmed the above findings.”

“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 interview, review of facility logs and the review of documentation, it was determined the facility failed to ensure that all equipment was maintained and operated in accordance with the manufacture’s recommendations. Findings: - Review of the daily disinfection logs between 01/01/2024 and 01/20/2025 revealed numerous weeks when a machine chemical/bleach disinfection was performed with no follow-up residual checks used to verify negative chemical residual prior to next use. Examples included, but were not limited to: * On 01/31/2024 all machines were disinfected with bleach. The “Residual” box was initialed as done at the end of the disinfection on 01/31/2024. On 02/01/2024, the “Residual” boxes were blank for all machines, an indication that staff failed to complete a second chemical residual test before the next patient use. * Similar findings were identified for the following dates when chemical disinfection was performed and the date the 2nd residual checks were required: 01/04/2025 and 01/05/2024, 02/07/2024 and 02/08/2024, 02/21/2024 and 02/22/2024, 02/28/2024 and 02/29/2024, 04/24/2024 and 04/25/2024, 05/01/2024 and 05/02/2024, 05/08/2024 and 05/09/2024, 05/22/2024 and 05/23/2024, 05/29/2024 and 05/30/2024, 06/05/2024 and 06/06/2024, 06/12/2024 and 06/13/2024, 06/26/2024 and 06/27/2024, 07/10/2024 and 07/11/2024, 07/17/2024 and 07/18/2024, 07/31/2024 and 08/01/2024, 08/28/2024 and 08/29/2024, 09/04/2024 and 09/05/2024, 10/23/2024 and 10/24/2024, 11/06/2024 and 11/07/2024, 11/13/2024 and 11/14/2024, 11/27/2024 and 11/29/2024. * The log sheet for 02/08/2024 was blank. * Staff failed to initial the heat disinfection performed on 08/08/2024 for all machines. * Staff failed to initial the heat disinfection performed on 11/21/2021 for machine #1. * On 01/15/2024, staff initialed the log but failed to indicate what disinfection procedure was performed and if the citric acid rinse was done. - Review of the 2% Citric Acid Mixing Logs between 01/01/2024 and 01/20/2025 revealed: * For the January 2024 log sheet, no times were recorded in the column “Preparation Date/Time.” * Similar findings were identified for February 2024, March 2024 and October 2024. * November 2024 log sheet was missing the time for the week of 11/18/2024. * December 2024 log sheet was missing the time for the week of 12/22/2024. - Review of the “CWP Daily Water Log” sheets between 01/01/2024 and 01/20/2025 revealed the “Test for Chemical Residual After” and “Check for Chemical Consumption” checks were not completed for 03/21/2024 and 03/28/2024. - During interview with the FA on 01/23/2025 at 1440, they verified that the July 2024 and August 2024 logs for the “Monthly Water Treatment Log-CWP ... Heat System Monthly Log” were not completed. They stated the “biomed at that time is no longer here.” Review of facility policy 1-15-01, “Fresenius Dialysis delivery System Cleaning and Disinfection Policy,” dated as last revised “April 2019” stipulated: * “At a minimum the facility specific log must include the following elements ... Serial number ... Date of procedure provided ... Type of procedure provided ... Cleaning/Descaling ... Disinfection (chemical and/or heat) ... Post chemical rinse residual test ... Verification of negative chemical residual test just prior to next use ... Status of equipment ... Teammate initials ... Signature/initials legend.” * “Teammates will perform a second chemical residual test on each dialysis delivery system that was chemically disinfected prior to the start of dialyzer set up and record on the facility’s ‘Dialysis Delivery System Cleaning and Disinfection Log.’” During interview with the FA and MCS on 01/22/2025 at 1555, the above findings were confirmed.”

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 31224 Based on interview, review of 7 of 7 patients’ plan of care (Patient #s 1-7) and review of documentation, it was determined the facility failed to ensure the patient’s right to be informed of and participate in all aspects of their care, including the right to refuse any intervention. Findings: Review of patient comprehensive assessments and signed plans of care revealed the plans of care were signed prior to completion of the comprehensive assessment or the finalizing of the plan of care. For example: Patient #1 signed that they acknowledged “review and approval of Patient Plan of Care at Interdisciplinary Team meeting” on 11/06/2024. However, the comprehensive assessment was not dated as final until 11/26/2024 and the plan of care was not dated as final until 11/27/2024. Patient #3 had a finalized plan of care dated 06/13/2024, but there was no documentation or signature to show the patient was informed of the concerns or interventions identified. Patient #4 signed that they acknowledged “review and approval of Patient Plan of Care at Interdisciplinary Team meeting” on 11/20/2024. However, the comprehensive assessment was not dated as final until 11/26/2024 and the plan of care was not dated as final until 11/27/2024. Similar findings were noted for Patient #s 2 and 5, 6 and 7. Review of facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” dated as last revised “October 2024,” stipulated, “The patient’s plan of care will be completed by facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or patient’s personal representative. If the patient chooses not to sign the plan of care, this choice will be documented on the plan of care, along with the reason the signature was not provided.” [sic] During interview on 01/22/2025 at 1615, the MSW confirmed the above findings. The MSW reported the IDT met monthly with the medical director to discuss the patient and patient concerns. The rest of the IDT would sign that the plan of care was approved at this meeting, prior to completion and finalization of either the comprehensive assessment or plan of care. The patient would be solicited for input at this meeting or interviewed for assessment shortly thereafter. The patient would sign that they had reviewed and approved the plan of care at that time, not when the plan of care was fully developed and finalized.”

“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: 37237 Based on interview, review of patient medical records and review of documentation, it was determined that the facility failed to ensure that patients received appropriate and timely hemodialysis monitoring or that the dialysis prescription was followed for 7 of 7 patients (Patients #s 1-7). Findings: Review of patients’ treatment flowsheets, “Treatment Details Reports,” revealed two sections titled “Intradialytic Vitals Stat Line.” The first section included a brief table of times and dialysis machine readings, at mostly routine times. The second section included two more detailed entries. One entry, “System Posted,” included the patient’s VS and other prescription readings taken from the dialysis machine and were automatically recorded every 30 minutes. The second entry was by PCTs/RNs and time stamped when staff did the actual patient evaluation, face and access visualization and heparin documentation. Review of patient treatment flowsheets reflected VS and safety checks were missed, RN assessments and prescription verifications were late, the patient’s dialysis prescription was not followed and/or abnormal findings were not reported to the RN. Examples included, but were not limited to: Patient #3 Review of patient #3 dialysis orders and treatment sheets dated 12/22/2024 through 01/20/2025 (13 hemodialysis treatments) revealed the following: - Patient VS, visualization and access checks were late for 10 of 13 treatments. * On 12/22/2024, the PCT documented a VS and access check at 0515. The next VS and access check was documented 77 minutes later at 0632. A VS and access check was done next 69 minutes later at 0741 and then 48 minutes later at 0829. * Similar findings were identified for treatment dates 12/24/2024, 01/01/2025, 01/06/2025, 01/08/2025, 01/10/2025, 01/13/2025, 01/15/2025, 01/17/2025 and 01/20/2025. - The RN verification of the dialysis prescription and initial patient assessment was late on 5 of 13 treatment dates. * On 12/22/2024, treatment was initiated at 0514. The RN verified the patient’s prescription 66 minutes later at 0620 and documented the initial assessment 77 minutes later at 0632. * On 12/30/2024, treatment was initiated at 0521. The RN verified the patient’s prescription 71 minutes later at 0632 and documented the initial assessment at 0853. The RN documented “Late documentation of pre-treatment assessment because this RN had to put on patients and attend to another patient’s needs/concerns.” The time of the actual initial assessment could not be determined. * Similar findings were identified for treatment dates 01/01/2025, 01/03/2025 and 01/08/2025. - The prescription for “Heparin Pork-Hourly Dose” was “Order Stop time for hourly dose before end of treatment ... 90 minutes.” Staff failed to stop the infusion as prescribed for 6 of 13 treatments. * On 12/27/2024 the heparin infusion was started at 0527 and ended at 0859. The patient’s treatment was terminated at 0847. * Similar findings were identified for 12/30/2024, 01/01/2024, 01/10/20258, 01/17/2024 and 01/20/2025. Patient #7 Review of Patient #7’s dialysis orders and treatment sheets dated 12/05/2024 through 01/18/2025 (13 hemodialysis treatments) revealed the following: - Patient VS, visualization and access checks were late for 12 of 13 treatments. * On 12/05/2024, the PCT documented a VS and access check at 1537. The next VS and access check was documented 124 minutes later at 1741. * Similar findings were identified for treatment dates 12/07/2024, 12/10/2024, 12/12/2024, 12/14/2024, 12/17/2024, 12/21/2024, 01/09/2025, 01/11/2025, 01/14/2025, 01/16/2025 and 01/18/2025. - The RN verification of the dialysis prescription and initial patient assessment was late on 4 of 13 treatment dates. * On 12/12/2024, treatment was initiated at 1404. The RN verified the patient’s prescription 191 minutes later at 1715 and documented the initial assessment at 2012. The RN documented “Late documentation of pre-treatment assessment because this RN had to put on patients and attend to another patient’s needs/concerns.” The time of the actual initial assessment could not be determined. * Similar findings were identified for treatment dates 12/17/2025, 01/09/2025 and 01/16/2025. - The patient’s BP was out of normal limits for 2 of 13 treatment dates. * On 12/07/2024, the patient’s BP readings were consistently low. At 1600, the BP was recorded as 86/73, at 1631, the BP was recorded as 99/56, at 1700 the PCT retook the BP and it was 69/39, at 1702 the PCT retook the BP and it was 66/40, at 1704 the PCT retook the BP and it was 82/51, at 1705/ the PCT retook the BP and it was 105/58 The PCT did frequent rechecks, but never notified the RN that the patient’s BP was low. * Similar findings were identified for treatment date 12/12/2024. Similar findings were noted for Patient #s 1, 2, and 4, 5 and 6. Review of facility policy 1-03-08, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” dated as last revised “April 2024” stipulated: * “ Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment ... The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law.” * “Patient identity, prescription, and machine settings are verified by teammate prior to initiation of treatment ...” * “Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: * “Vital signs and treatment monitoring ... are completed at least every 30 minutes.” * “At a minimum, obtain and document the following ... Blood pressure ... Heart or pulse rate ... Blood and dialysate flows, arterial and venous pressures ... Fluid removal and/or replacement ... Vascular access visible and line connections intact ... Patient subjective statement(s) i.e., patient report on overall health, any complaints.” * Abnormal findings “should be reported to the licensed nurse and documented in the patient’s medical record.” Abnormal findings included SBP “greater than 180 mm/Hg or less than 90 mm/Hg” and DBP “greater than or equal to 100 mm/Hg or less than 50 mm/Hg.” During interview with the CN on 01/23/2025 at 1100, they confirmed that prescription verifications and initial patient assessments were done late and/or charted late due to the work load of the RNs. During interview with the FA and MCS on 01/23/2025 at approximately 1430, they confirmed the above findings.”

“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: 31224 Based on interview and review of documentation, it was determined that the facility failed to assess and offer vaccines as indicated. The facility failed to: * Identify patients whose pneumococcal vaccines were complete for 26 of 65 patients (Patient #s 5, 7, 9, 17, 19, 22-24, 27, 28, 30, 34-36, 39, 41, 45-49, 54, 56, 59, and 65); * Offer a pneumococcal vaccine to eligible patients for 25 of 65 patients (Patient #s 2, 3, 11-16, 18, 21, 29, 32, 33, 37, 38, 50-53, 55, 57, 58, 61-65); * Identify the appropriate timeframe to offer the next available dose of the pneumococcal vaccine for 8 of 65 patients (Patient #s 4, 12, 20, 25, 26, 31, 43, and 44); and * Reassess prior refusal of the pneumococcal or Hepatitis B vaccines for 3 of 65 patients (Patient #s 42, 50, and 60), and * Ensure the spreadsheets used to track vaccination status included all patients for 1 of 65 patients (Patient #66). Findings: Review of the facility’s “Vaccination and Surveillance Report,” dated 01/21/2025, the Hepatitis B vaccine tracking spreadsheet provided on 01/28/2025, and the pneumococcal vaccine tracking spreadsheet provided on 01/28/2025, revealed: 1. Patient #s 5, 7, 9, 17, 19, 22-24, 27, 28, 30, 34-36, 39, 41, 45-49, 54, 56, 59, and 65 had received a dose of PCV20 and their pneumococcal vaccinations were complete. However, the pneumococcal vaccine tracking spreadsheet identified a future date to offer the PCV20. For example: * Patient #5 received PCV20 on 03/11/2024 and did not require any additional vaccinations. The tracking spreadsheet identified Patient #5 would be offered PCV20 again on 03/01/2029. * Patient #7 received PCV20 on 08/27/2024 and did not require any additional vaccinations. The tracking spreadsheet identified Patient #5 would be offered PCV20 again on 03/01/2029. * Patient #17 received PCV20 on 02/08/2023 and did not require any additional vaccinations. The tracking spreadsheet identified Patient #5 would be offered PCV20 again on 02/08/2028. * Similar findings were noted for Patient #s 9, 19, 22-24, 27, 28, 30, 34-36, 39, 41, 45-49, 54, 56, 59, and 65. 2. Patient #s 2, 3, 11-16, 18, 21, 29, 32, 33, 37, 38, 50-53, 55, 57, 58, 61-65 were eligible to receive the PCV20 vaccine due to their documented vaccination status. For example: * Patient #2 received one dose of PPSV23 on 01/01/2018 and was eligible to receive PCV20 as of 01/01/2019, but there was no documentation to show it was offered or received. * Patient #13 received two unknown pneumococcal vaccines on 06/17/2010 and 02/04/2020 per the “Vaccinations and Surveillance Report.” The pneumococcal vaccine tracking spreadsheet only identified one dose of PPSV23 was given on 02/04/2020. Patient #13 was eligible to receive PCV20 on 02/04/2021 due to what was known of their vaccination history, but there was no documentation to show it was offered or received. * Patient #14 received an unknown vaccination on 05/12/2020 per the “Vaccinations and Surveillance Report” and no vaccines were identified on the pneumococcal vaccine tracking spreadsheet. Patient #14 was eligible to receive the PCV20 vaccine, but there was no documentation to show it was offered or received. * Similar findings were noted for Patient #s 3, 11, 15, 16, 18, 21, 29, 32, 33, 37, 38, 50-53, 55, 57, 58, 61-65. 3. Patient #s 4, 20, 25, 26, 31, 43, and 44 had a documented history of known pneumococcal vaccinations, but the correct date for when the patient was eligible to receive the PCV20 vaccine was not identified on the pneumococcal vaccine tracking spreadsheet. For example: * Patient #4 had a documented history of receiving PCV13 on 09/09/2019 and PPSV23 on 09/23/2020 prior to the age of 65. They would be eligible to receive PCV20 on 09/23/2025, however the pneumococcal vaccine tracking spreadsheet identified their eligibility date as 01/27/2025. * Patient #31 had a documented history of receiving PCV13 on 03/03/2021 and PPSV23 on 10/06/2021 prior to the age of 65. They would be eligible to receive PCV20 on 10/06/2021, however the pneumococcal vaccine tracking spreadsheet identified their eligibility date as 01/27/2025. * Patient #44 had a documented history of receiving PCV13 on 10/06/2015 and PPSV23 on 12/03/2021 after the age of 65. They would be eligible for an optional dose of PCV20 on 12/03/2026, however the pneumococcal vaccine tracking spreadsheet identified their eligibility date as 01/27/2025. * Similar findings were noted for Patient #s 20, 25, 26, and 43. 4. Patient #s 42, 50 and 60 had a prior history of refusing the Hepatitis B and/or the pneumococcal vaccine, however there was no documentation to show they were reassessed annually or that the refusal was noted on the corresponding vaccination tracker. For Example: * Patient #42 refused the pneumococcal vaccine on 01/11/2024 per the “Vaccination and Surveillance Report” but this was not reflected on the pneumococcal vaccine tracking spreadsheet. * Patient #50 refused the Hepatitis B vaccine on 11/04/2019, however there was no documentation to show they were reassessed since then. *Patient #60 refused the Hepatitis B and pneumococcal vaccines on 03/02/2022. There was no documentation to show they were reassessed since then. 5. Patient #66 was identified on the “Vaccinations and Surveillance Report” as having immunity to Hepatitis B and receiving PCV13 and PPSV23 after the age of 65. However, Patient #66 was not included on either the Hepatitis B or pneumococcal vaccine tracking forms. 6. Review of the facility policy titled, “Pneumococcal Vaccination for Adult Patients,” dated as last revised “October 2023,” stipulated: * Patients of any age who received only PCV13 or PPSV23 would be given PCV20 at least one year after the most recent vaccine to complete the series. * Patients who had received PCV13 and PPSV23 before age 65 would receive PCV20 at least 5 years after the most recent pneumococcal dose to complete the series. * Patients who had received PCV13 and PPSV23 after age 65 could receive an optional dose of PCV20 at least 5 years after the most recent pneumococcal dose to complete the series. * The policy did not address what should be administered to a patient with an unknown vaccination history. * The policy did not address reassessing whether a patient wished to receive the pneumococcal vaccine after a refusal. 7. Review of the facility policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance,” dated as last revised “April 2024,” did not address reassessing whether a patient wished to receive the Hepatitis B vaccines after a refusal. 8. Review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” dated as last revised “October 2024,” stipulated: * “Assessment criteria will include ... immunization history...” * “A comprehensive re-assessment of each patient and a revision of the plan of care will be conducted: - At least annually for stable patients ... - At least monthly for unstable patients ...” 9. The CDC guidelines for administering pneumococcal vaccines to adults age 14-49 with ESRD or age 50 and older at https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-notes.html#note-pneumo included: * “Not previously received a dose of PCV13, PCV15, PCV20, or PCV21 or whose previous vaccination history is unknown: 1 dose PCV15 or 1 dose PCV20 or 1 dose PCV21. - If PCV15 is used, administer 1 dose PPSV23 at least 1 year after the PCV15 dose (may use minimum interval of 8 weeks for adults with an immunocompromising condition ... cochlear implant, or cerebrospinal fluid leak).” * “Previously received only PCV13: 1 dose PCV20 or 1 dose PCV21 at least 1 year after the last PCV13 dose. * “Previously received only PPSV23: 1 dose PCV15 or 1 dose PCV20 or 1 dose PCV21 at least 1 year after the last PPSV23 dose. - If PCV15 is used, no additional PPSV23 doses are recommended.” * “Previously received both PCV13 and PPSV23 but NO PPSV23 was received at age 65 years or older: 1 dose PCV20 or 1 dose PCV21 at least 5 years after the last pneumococcal vaccine dose.” * “Previously received both PCV13 and PPSV23, AND PPSV23 was received at age 65 years or older: Based on shared clinical decision-making, 1 dose of PCV20 or 1 dose of PCV21 at least 5 years after the last pneumococcal vaccine dose.” During interview on 01/23/2025 at 1100 and via email received on 01/28/2025, the CN confirmed the above findings.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 31224 Based on interview, review of 7 of 7 patients’ plan of care (Patient #s 1-7) and review of documentation, it was determined that the facility failed to ensure that plans of care were signed by the patient and/or the patient’s designee or that a reason for refusal was documented. Findings: Review of patient comprehensive assessments and signed plans of care revealed the plans of care were signed prior to completion of the comprehensive assessment or the finalizing of the plan of care or not signed by the patient. For example: Patient #1 signed that they acknowledged “review and approval of Patient Plan of Care at Interdisciplinary Team meeting” on 11/06/2024. However, the comprehensive assessment was not dated as final until 11/26/2024 and the plan of care was not dated as final until 11/27/2024. Patient #3 had a finalized plan of care dated 06/13/2024 that was signed by the IDT on 06/03/2024, but there was no patient signature or documentation as to why the patient may have refused to sign. Patient #4 signed that they acknowledged “review and approval of Patient Plan of Care at Interdisciplinary Team meeting” on 11/20/2024. However, the comprehensive assessment was not dated as final until 11/26/2024 and the plan of care was not dated as final until 11/27/2024. Similar findings were noted for Patient #s 2 and 5-7. Review of facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” dated as last revised “October 2024,” stipulated, “The patient’s plan of care will be completed by facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or patient’s personal representative. If the patient chooses not to sign the plan of care, this choice will be documented on the plan of care, along with the reason the signature was not provided.” [sic] During interview on 01/22/2025 at 1615, the MSW confirmed the above findings. The MSW reported the IDT met monthly with the medical director to discuss the patient and patient concerns. The rest of the IDT would sign that the plan of care was approved at this meeting, prior to completion and finalization of either the comprehensive assessment or plan of care. The patient would be solicited for input at this meeting or interviewed for assessment shortly thereafter. The patient would sign that they had reviewed and approved the plan of care at that time, not when the plan of care was fully developed and finalized.”

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors. This Standard is not met as evidenced by: 37237 Based on interview, QAPI review and review of documentation, it was determined the facility failed to implement a quality assurance program that achieved measurable patient improvement by using indicators or performance measures. Findings: During review of the QAPI program on 01/23/2025 beginning at 1445, the facility failed to demonstrate the only improvement plan in place was developed, implemented, updated and monitored. The data reviewed during QAPI review was from the facility’s December meeting that reviewed the facility data from November. - The one improvement plan that was examined during QAPI review was for the frequency that patients’ post treatment weights were above the prescribed target weights, “Freq Post Wt Above TW %Pt”. The original “IP Start Date” was implemented 09/28/2022. The “Anticipated IP Completion” date was 09/28/2023. The “Action(s) and Interventions” listed were: “Identify patients that needed interventions ...” “Educate the patients ...” “Investigate the cause of not meeting the TW post treatment” “Notify MD ...” “Assess and adjust TW accordingly.” There was no documentation that any of the “Action(s) and Interventions” were completed. There were no monthly reviews, no changes in the Actions and Interventions and no documentation that demonstrated performance improvement. The IP failed to include an evaluation of the effectiveness of the interventions in place or identify new approaches when there was a lack of improvement. Also, there was no documentation to show the IP was kept open or ever closed. The only items that were dated in the overall Improvement Plan were in the section “Baseline Process and Results.” The three items listed were: * “Total of 26 patients or 41.9% out of 62 performance census for the month of Dec2024.” * “Total of 26 patients or 39.4% out of 66 performance census for the month of NOV2024.” * “Total of 21 patients or 32.3% out of 65 performance census for the month of OCT2024.” During the review of the IP, the FA stated that the IP will be closed when reviewing December’s facility data [in January 2025] and a new IP well be started for January 25 [Facility data for January 2025 will be reviewed in February 2025]. - The facility’s QAPI program failed to identify issues identified during the recertification survey, such as patient monitoring, infection control, vaccines and technical logs. - The facility failed to provide QAPI meeting minutes for the past 6 months. Review of facility policy 1-14-06, “Continuous Quality Improvement Program,” dated as last revised “April 2021” stipulated: * “Facility Administrators (FAs) conduct periodic Facility Health Meetings (FHM) (also known as QAPI in CMS Conditions for Coverage) with the CQI committee to review issues and indicators regarding facility’s management and performance. FHM’s are conducted monthly.” * “Written documentation and plans of action will be documented within the FHM application known as Facility Health Record and will be maintained in a confidential manner. Copies of the CQI meeting minutes will be provided upon request to CMS.” * “Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any are identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained.” During QAPI review on 01/23/2025 beginning at 1145, the FA confirmed that the improvement plan that was reviewed was only one improvement plan in place.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 37237 Based on interview and review of personnel files, it was determined the facility failed to ensure that 11 of 13 staff members (Staff #s 2, 3, 4, 5, 6, 7, 8, 10, 11, 12 and 13) had an up-to-date personnel file and had the qualification and demonstrated competencies required to meet the comprehensive care needs of the patients. Findings: The review of documentation included an audit worksheet document of the facility staff training records which was completed by the FA on 01/23/2024. The worksheet included 16 categories for training and competency that staff were required to have completed and documented in their personnel file. Review of the worksheet revealed a list of 13 facility staff members. The worksheet revealed numerous gaps in the required personnel documentation. Examples included, but were not limited to: - 3 of 13 staff (Staff #s 2, 3 and 12) lacked current documentation of “Emergency Procedures Training.” - 1 of 13 staff (Staff # 13) lacked current documentation of “EP Disaster Training.” - 6 of 10 clinical staff (Staff #’s 3 - 7 and 9) lacked current documentation of “H2O Dialysate Training.” - 1 of 13 staff (Staff # 8) lacked current documentation of “Hepatitis B Vaccine or Decline”. The date listed was 01/21/2025 while the surveyors were on-site for the recertification survey. - 2 of 13 staff (Staff #s 3 and 6) lacked current documentation of “Date of Last Annual Evaluation.” * Staff #3, with a DOH of 09/18/2016, had a last annual evaluation on 08/31/2023. * Staff #6, with a DOH of 06/05/2023, had a last annual evaluation on 12/31/2023. During an interview with the FA and MCS on 01/23/2025 at approximately 1530 the above findings were confirmed.”