Pnrs Hollywood Dialysis

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 31224 Based on interview, review of facility personnel files, review of patients’ medical records, review of policies and procedures and review of the facility’s Emergency Preparedness binder, it was determined the facility failed to comply with the Federal Emergency Preparedness (EP) requirement to maintain a comprehensive EP program, 42 CFR § 494.62 - Condition of participation: Emergency preparedness. This condition-level deficiency substantially limits the capacity of the facility to furnish services of an adequate level of quality. Findings: The facility failed to maintain a comprehensive EP program, as evidenced by the following: 1. Complete an annual hazard and vulnerability assessment. The last date for completion was 01/01/2022. 2. Implement an Emergency Preparedness Training and Testing program: * The clinic failed to provide documentation of participation in any community or tabletop emergency exercises since 2020; * The clinic failed to document whether all patients received emergency preparedness or emergency procedure training. 3. Patient contact information was outdated or missing. * Pediatric patient list was dated 07/2022. * No adult patient contact list was found in the EP or crash cart binders. 4. Facility emergency contact information was last updated in 04/2021 and was outdated. 5. The Emergency Information Directory with staff contact information was last revised in 08/02/2017 in the emergency cart binder or 07/01/2022 in the emergency preparedness binder and was outdated. 6. Annual letters to the local emergency preparedness agency and other emergency preparedness collaborators were last sent in 11/2021. 7. On 08/29/2023 at 1040, the adult crash cart was observed unlocked, which left the medications unsecured. 8. The pediatric crash cart was observed to have expired medications, including: * 10 vials of naloxone dated 02/2023. * 4 vials of adrenalin dated 07/2023. * 2 vials of naloxone dated 07/2023. * 2 vials of diphenhydramine dated 07/2023. During interview on 08/29/2023 at 1045, the DO confirmed findings #7 and 8. During interview on 08/29/2023 at 1100, the FA confirmed findings #1-6.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 37237 Based on observations, interviews and review of documentation, it was determined that the Governing Body failed to: - Ensure the care and safety of patients; - Ensure all patients were treated with respect and dignity; and - The Emergency Preparedness plan was current and that patient and staff contact information was up-to-date. - Ensure the internal grievance process was followed. This condition-level deficiency substantially limits the capacity of the facility to furnish services of an adequate level of quality. Findings: Refer to findings identified in tags V110, V450, V765 and E003.”

“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, interview and review of facility policies, it was determined the facility failed to provide and monitor a sanitary environment to minimize the transmission of infectious agents within the dialysis unit. Findings: During observation of the facility on 08/29/2023 at 1010, a PCT was giving care in and out of a patient’s treatment area on the general dialysis treatment floor. At 1020 this surveyor initiated a conversation with this patient. During the conversation, the patient told the surveyor that they tested positive for COVID-19 that morning. Both the PCT and the patient were wearing surgical masks. The PCT was working and moving between 3 patients within the pod. The surveyor asked the FA if they were aware of the patient with COVID-19. The FA stated they were not aware that any of the patients currently had COVID-19. At approximately 1100, the FA stated that the PCT had not been told the patient was COVID-19 positive, but the RN was aware. Review of the facility policy, “Guidance on Dialyzing and Infection Control Practices of COVID-19 in Fresenius Kidney Care (FKC) Dialysis Clinics,” dated as “Published 05/19/2023 ... Version 4” stipulated on page 7 in the section titled “Cohorting COVID-19, PUI and CCE Patients” that “COVID-19 positive patient may be cohorted and treated within their home clinic treatment shift with appropriate infection control precautions in place. When COVID-19 positive, PUI or CCE patients are being treated within the home clinic or program, the patient should be masked with an N95 respirator mask and treated at a corner or end-of-row station away from the main flow of clinic traffic ... Each classification of patients (i.e., COVID-19 positive, PUI, and CCE) must be cohorted in distinct locations on the treatment floor and classifications of patients should not be intermingled with each other ... FKC staff members who are directly caring for PUI, or COVID-19 patients must wear gown, gloves, face shield and an N95 respirator mask ... Take precautions to avoid crossover and intermingling of COVID-19 positive and PUI patients with negative patients ... When possible, there should be dedicated staff for PUI and COVID-19 positive cohorts with no crossover to provide care to asymptomatic and COVID-19 negative patients. If there are shared staff members between the PUI and COVID-19 classifications and negative patients, the staff member must wear dedicated PPE in caring for the COVID-19 positive and PUI patients.””

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 37237 Based on interview and review of documentation, it was determined that the facility failed to ensure that HBV serological tests were drawn and that the hepatitis status of susceptible patients were monitored in order to manage care appropriately. Findings: Review of the facility’s “Hepatitis B Summary Report,” created “08/29/2023,” that included documentation of Hepatitis B vaccination status of 48 patients, revealed 13 of 48 patients with HBsAb less than 10 failed to have monthly ABsAg monitoring documented. Review of the facility policy titled, “Patient Hepatitis B Testing Requirements,” dated as “Published 01/07/2022 ... Version: 2” stipulated in the section “HBV Patient Testing” that monthly HBsAg testing is required when a patient is determined “Susceptible ... Anti-HBs: less than 10mlU/ml.” During interview with the DO on 08/31/2023 at 1100, the above findings were presented. Detailed information was discussed with the DO and the above findings were confirmed.”

“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: 37237 Based on interview and review of documentation, it was determined the facility failed to ensure that all susceptible patients were offered vaccination against Hepatitis B. Findings: Review of the facility’s “Hepatitis B Summary Report,” created “08/29/2023,” that included documentation of Hepatitis B vaccination status of 48 patients revealed 15 patients who were determined susceptible lacked documentation of receiving the vaccine series, the vaccine series was incomplete or the vaccine series was incorrectly administered. Review of the facility policy titled, “Patient Vaccination for Hepatitis B,” dated “02/07/2022 ... Version: 5” stipulated “The Hepatitis B vaccine shall be offered to all susceptible patients including peritoneal and home dialysis patients.” The policy provided guidelines for offering vaccination series or booster doses. During interview with the DO on 08/31/2023 at 1100, the above findings were presented. Detailed information was discussed with the DO and the above findings were 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: 47148 Based on interview and review of documentation, it was determined that the facility failed to ensure that all employees responsible for operating, testing and monitoring the water and dialysate systems completed the required training and annual skills checks required by facility policy and this regulation. Findings: Review of the facility’s digital Hourly TCL Logs for June 2023 and July 2023 revealed: * On 06/13/2023, the “1339” reading was “Confirmed By” Staff #31. Similar findings on 06/15/2023, 06/17/2023 and 06/20/2023 were identified. * On 07/11/2023, the “0744” and “1038” readings were “Confirmed By” Staff #31. In an email dated 09/27/2023, the ATL reported Staff #31 completed the required training on 09/01/2023 and confirmed they had not completed the water room skills check off prior to conducting the above checks. Failure by the facility to ensure that all staff had received the required water room training could result in the contamination of the water system and/or incorrectly mixed dialysate. Exposure to contaminated water or incorrectly prepared dialysate could potentially result in serious negative effects for the patients, including but not limited to, pyrogenic reactions, bacteremia and serum electrolyte imbalance and subsequent complications.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 47148 Based on observation and interview, it was determined the facility failed to ensure the dialysis facility was maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. Findings: Observations of the facility on 08/29/2023 included, but were not limited to: 1. Physical Environment * A staff member’s bicycle was parked in the middle of the treatment floor. * Dry, white precipitate on the front of cabinet drawers in clean prep areas, on garbage cans and on biohazard cans. * Trash on the floor near several patient stations and in common walk areas, including but not limited to food wrappers and used gloves. * Arm pillows for patient chairs found on the floor between patient stations. * Throughout the treatment floor, items were stored behind the machines on the wall boxes. Items included, but not limited to jugs of Citrasate, patient chair arm pillows, clothing, and ancillary equipment. * Several wall boxes contained a white precipitate. * A plastic jug containing an unknown liquid, which lacked a lid, was stored behind a patient station. * A sink labeled as “Dirty” had soap and a paper towel dispenser available for use. A dirty sink is designed to use primarily for disposal and not cleaning. A sink with soap and paper towels available for use could easily be mistaken for a handwashing sink. 2. Expired items/medications * An opened MDV of Heparin Sodium Injection 30,000 USP Units/30 mL lacked an opened date, BUD, and initials of the person who opened it. * An opened 2 mL vial of Lidocaine 1% lacked an opened date, BUD, and initials of the person who opened it. * 29 3-packs of Povidone-Iodine swab stick applicators had an expiration date of October 2022. * Two single-packs of Povidone-Iodine swab stick applicators had an expiration date of July 2023. * An opened bottle of “WaterCheck Residual Chlorine” reagent strips lacked an opened date. The bottle is clearly marked, “Use within 3 months after opened.” * A package of 2.7 mL blue-topped blood collection tubes expired 07/31/2023. * Four single-dose prefilled syringes of “Influenza Vaccine Fluzone High-Dose Quadrivalent” vaccine with an expiration date of 06/30/2023. * An opened MDV of Tuberculin Purified Protein Derivative (Mantoux) lacked an open date, BUD and initials of the person who opened it. It was labeled “opened 7-27” outside of the box package. Without a full date, the expiration date is unable to be determined. * An opened MDV of Tuberculin Purified Protein Derivative (Mantoux) had a handwritten note “opened 7/10/23 Exp 8/9/23 SK.” * Two unopened vials of Adrenalin 1mg/mL expired on 07/2023. * Two unopened vials of Naloxone 0.4mg/mL expired on 07/2023. * An opened bottle of “Mesa Lab Standard Buffer Solution 10.00 pH” lacked an opened date. Clearly marked on the front of the solution bottle, “Discard 90 days after opening.” * Two 32-oz containers of LiquaCel Grape Concentrated Liquid Protein expired May 2023. * One 32-oz container of LiquaCel Peach Mango Concentrated Liquid Protein expired January 2023. * One 32-oz container of LiquaCel Peach Mango Concentrated Liquid Protein expired June 2023. * Two boxes of 25-count Providone-Iodine swab sticks expired 10/2022. * Six boxes of 50-count transparent dressings: 1 box expired 03/2023, 1 box expired 05/2023, and 4 boxes expired 06/2023. * One box of Durapore tape expired 08/13/2023. * Five bottles of “SteriChek Sensitive Low-Range Water Hardness Reagent Strips” were expired: 1 bottle expired 01/2023, 3 bottles expired 03/2023, and 1 bottle expired 04/2023. On 08/29/23 at approximately 1035, a staff member was asked why the bicycle was parked on the treatment floor when there was a designated bicycle parking area outside of the lobby area and they stated, “I have no idea why that is there.” Review of current CDC guidelines for “Injection Safety” stipulated “If a multi-dose vial has been opened or accessed (e.g. needle-punctured), the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.” During an interview with the FA on 08/29/2023 at 1155 and at approximately 1600, the above findings were confirmed.”

“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: 47148 Based on interview and the review of documentation, it was determined that the facility failed to ensure that all equipment was maintained and operated in accordance with the manufacturer’s recommendations. Findings: Review of the facility’s digital logs for May 2023 through August 2023 revealed: “Helmer Medication Refrigerator Log” - May 2023: * On 05/09/2023, no PM temperature was recorded; and * On 05/25/2023, no PM temperature was recorded; - June 2023 * On 06/05/2023, the PM temperature was recorded at “0414;” and * On 06/20/2023, the AM temperature was recorded at “1923.” “Glucose Meter Log” - May 2023 * Missing entry for 05/23/2023. - June 2023 * On 06/28/2023, the “Test Strip Expiration Date” was entered as “06/15/2023;” and * On 06/06/2023, the “90-days Expiration Control 2” was entered as “06/06/2023.” - July 2023 * Missing entry for 07/06/2023; * On 07/19/2023, the “Test Strip Expiration Date” was entered as “07/19/2023;” and * On 07/22/2023, the “Test Strip Low Range” was “92-124.” The value of “125” was documented as the “Low Result” without any note indicating any action was taken due to the out of range result. “AED - Zoll (Daily) Log” - June 2023 * Missing entries on 06/08/2023, 06/10/2023, 06/13/2023, 06/20/2023. “Hourly TCL Log” - May 2023 * On 05/11/2023, the “0520” hourly reading was completed late at “0609,” after patients had their hemodialysis initiated; * On 05/20/2023, the “0520” hourly reading was completed late at “0531;” and * On 05/30/2023, the “1811” hourly reading was completed late at “1832.” - June 2023 * On 06/13/2023, the reading was “Confirmed By” Staff #31. An email discussion with the ATL on 09/27/2023 confirmed Staff #31 had not completed a water room skills check-off prior to the survey. Similar findings were identified for 06/15/2023, 06/17/2023 and 06/20/2023. - July 2023 * On 07/11/2023, the “0744” reading was “Confirmed By” Staff #31 who failed to have a water room skills check-off completed. A similar reading at “1038” was found; and * On 07/29/2023, the “1629” hourly reading was completed late at “1638.” Review of the “Daily Patient Schedule” revealed that patients start their hemodialysis treatment at 0520 on the TTS shift. “2% Citric Acid Container Solution Mixing Log” - May 2023 * Missing entries on 05/01/2023, 05/03/2023, 05/05/2023, 05/06/2023, 05/08/2023, 05/17/2023, 05/18/2023 and 05/19/2023. * On 05/23/2023, the “Packet Use By Date” was entered as “10/01/01.” - June 2023 * Missing entry on 06/15/2023. - August 2023 * Missing entries for 08/10/2023, 08/14/2023, 08/25/2023, 08/26/2023 and 08/28/2023. “Storage Room Temperature Log” for Room #1 - May 2023 * On 05/13/2023, “0459” was entered instead of a temperature; * On 05/16/2023, “0500” was entered instead of a temperature; * On 05/18/2023, “0450” was entered instead of a temperature; * On 05/25/2023, “0500” was entered instead of a temperature; and * On 05/30/2023, “0455” was entered instead of a temperature. - June 2023 * On 06/01/2023, “0459” was entered instead of a temperature; * On 06/03/2023, “0500” was entered instead of a temperature; * On 06/06/2023, “0455” was entered instead of a temperature; * On 06/08/2023, “0500” was entered instead of a temperature; * On 06/10/2023, “0500” was entered instead of a temperature; and * On 06/15/2023, “0500” was entered instead of a temperature. “O2 Concentrator (Weekly) Log” - July 2023 Documentation on 07/29/2023 revealed staff failed to clean the oxygen concentrator filters on 10 of 15 machines. - August 2023 Documentation on 09/19/2023 revealed staff failed to clean the oxygen concentrator filters on 4 of 15 machines.”

“PR-RESPECT & DIGNITY CFR(s): 494.70(a)(1) The patient has the right to- (1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD This Standard is not met as evidenced by: 37237 Based on interview and the review of documentation, it was determined the facility failed to ensure the patients’ right to be treated with respect, dignity and recognition of their individual and personal needs, and sensitivity to their psychological needs. Findings: Staff #33 All personnel documentation for Staff #33 was received via email from FMC on 11/08/2023. Review of the personnel “Job Data” file revealed that Staff #33 was terminated effective 08/26/2023 for “Inv-Violation of Policies.” Review of the undated performance review for “Performance Year: 2021” revealed in the “Goals” section that “Goal Title ... Stay focused and prioritize [your] tasks. Expected Result ... Continue to be less distracted and prioritize tasks. Make less (sic) mistakes, ie (sic): entering incorrect treatment information, hours, etc. Double check all work before leaving station ... Manager comments: The mistakes continue to occur. Incorrect treatment time or goal are noted at times, incorrect med drawn up, etc. Fortunately, [Staff 33] or a staff member find it before it becomes an issue or problem. Needs to clarify treatment notes to reflect actions done for high/low Vital Signs. It is so important to document these interventions and the follow up.” The performance review lacked measurable perfomance measures, a manager’s signature and lacked any employee comments, self-ratings or signature. It could not be determined from the documentation presented if the evaluation with the goal expectations was discussed or reviewed with Staff #33. Review of the undated performance review for “Performance Year: 2022” revealed nothing was documented in the “Goals” section. In the section titled “Overall” it was documented “Manager Overall Final rating 4 - Needs improvement ... Areas for improvement [Staff #33] needs to take time to do the eCube Master class ... also needs to also be aware of policies and procedures in place.” The performance review lacked a dated signature from the employee and the manager. In the section for signatures, “False” is listed for both. The performance review also lacked any employee comments or self-ratings. It could not be determined from the documentation presented if the goals outlined in the 2021 performance review were met and if the 2022 evaluation was discussed or reviewed with Staff #33. Review of Staff #33’s learning transcripts revealed the last eCube training was completed on 8/16/2017. Further review of Staff #33’s education and training revealed: The last “Annual Compliance Training” was completed 11/01/2021. The last “Annual Clinical Skills Validation and Exam for RNs” was completed 06/20/2022. The last “Annual Water Training” was completed 03/10/2022. Review of the “Outpatient CAP RN 2” job description signed by Staff #33 on 03/01/2019 revealed “The CAP RN 2 is accountable and responsible for the provision and coordination of clinically competent care including assessment, planning, intervention and evaluation for an assigned group of patients ... Serves as a leader, coach, mentor and role model for new and incumbent employees by setting examples of appropriate behavior, work habits and attitudes towards patients, co-workers, supervisors and the company at the facility and area level.” In the “Experience and Required Skills” section, the job description stipulated “Successful completion of all annual required education/training/competencies ... Successful completion of on-going training and education as assigned or required.” No further documentation was provided to ensure Staff #33 was trained, educated, coached or put on a performance plan to improve or meet overall expectations outlined in the “Outpatient CAP RN 2” job description. Review of personnel documentation provided by FMC on 11/08/2023 revealed an email sent to the ATL by Staff #34 on 01/25/2023. The subject of the email was “Inappropriate situation with [Staff #33]” Staff #34 wrote “I’m reaching out because we had an incident between [Staff #33] and [Patient 1] today ... [Staff #33] was assessing [Patient 1] and then asked for a hug. [Patient 1] said ‘no’ and [Staff #33] proceeded to go in for a hug after which [Patient 1] said ‘no’ again. [Staff #33] said something to the effect of ‘oh, come on it’s fine.’ [Patient 1] then firmly, and clearly uncomfortable said, ‘no means no’. [Staff #33] then said ... ‘Well, I tried ... you had your chance.’ [Patient 1] responded by saying ‘I didn’t want a chance’. [Staff #33] continued to say multiple times to [Patient 1] that [they] ‘hurt [Staff #33’s] feelings.’” Review of personnel documentation provided by FMC on 11/08/2023 revealed an email sent to the ATL by Staff #35 on 03/03/2023. A pediatric nephrologist was cc’d. The subject of the email was “Situations and Concerns this week in Pediatrics.” Staff #35 wrote “Monday was [Patient 2’s] first treatment ... [They are] very good about staying still and not moving [their] arm at all during blood pressures. At one point ... [another staff] and I heard [them] whining and fussing. [Staff #33] was holding [their] harm [sic] quite firmly, upsetting [them]. [Patient 2] was then crying and upset through the rest of the treatment ... Wednesday, it happened again. [Patient 2] was fine and calm and ... had suddenly got worked up and was crying. [Staff #33] was over there firmly holding [them] down during [their] blood pressure ... [Staff #33] then firmly stated ‘well [they] are new and [Patient 2] is gonna (sic) to learn!’ [Patient 2] is 3 years old ... I told [Staff #33] it’s just not necessary to restrain [them] or hold [their] arm ...” The email also listed numerous situations where the RN was unable to perform tasks to standard, i.e., “Multiple times a day, we have to have the same exact conversation yet there is no understanding ... We have to ask for a second verification and assessments multiple times and still will not get one.” And “There has been some upsetting comments towards [Patient 3] regarding unclamping [their] CVC ... Today [Staff #33] came up and said ‘Two and a half years [Patient 3] and nothing has changed. Its (sic) like you don’t even care do you? You don’t care on what happens to you ...’” Also “About a month ago, [Staff #33] told [Patient 3] ‘Every morning I wonder if you are going to be alive or if you bleed (sic) to death because you just don’t care.’ ... this seems to be really negatively impact (sic) [Patient 3] and doesn’t seem beneficial.” Review of the Human Resources document “Corrective Action Form” for [Staff # 33] presented by FMC via email on 11/08/2023 revealed “List all applicable date(s) for this incident/occurrence ... 8/9/2023.” Under the “Reason for corrective action” the form lists “Violation of Behavior in the Workplace policy ... Violation of Core Values ... Violation of Patient Rights and Responsibilities.” Also listed under “Reason for corrective action” was “On August 11, 2023, a complaint was received regarding interaction [Staff #33] had with a pediatric patient. Investigation findings revealed that on August 9, 2023 [Staff #33] failed to respect professional boundaries in an interaction with a pediatric patient. In January 2023, [Staff #33] was coached and reminded of expectations concerning professional boundaries.” In the section of the form “Current Corrective Action” the only box checked was “Level 3 - Termination of Employment.” The Corrective Action Form was signed by the RVP and Lead ER Mgr and dated 08/25/2023. Review of the document, “Case: FMCNA-2023-8-8079-Compliance Action Line - Web HR Harassment / Discrimination,” section “Case Details” revealed “Is management aware of your concern? Yes ... If yes, then who? ... I was uncomfortable going to our direct management due to a recent issue of our manager breaking confidentiality of a concern with this particular RN ... So I went to my Medical director and [they were] going to reach out to my FA and ATL. [The Medical Director] told me to file this report right away.” Written under “Details: We have an RN that has had a history of pushing the boundaries with our pediatric patients physically. In this event, [they] asked if [they] get a kiss from one of our pediatric patients ... [They] proceeded to kiss [them] on the lips (with masks on both). This particular Child is the age of 6 BUT with the mental capacity and the size of a toddler/18month old ... My medical director told me I should make aware this is not the first incident... I had reported this to management in an email. I am extremely concerned that after [Staff #33] is talked to, this could create a very awkward and hostile environment. I was the only person present and [they] will know I am the one who spoke up.” From the review of the documentation provided, the facility failed to take action against the RN prior to the complaint filed with the corporate office. The facility failed to provide any other documentation of corrective actions taken regarding the complaints to the ATL dated 01/25/2023 and 03/03/2023. Documentation of education, coaching, or training of expectations concerning professional boundaries was not provided. Review of the facility policy, “Patient Rights and Responsibilities,” dated as last revised “04/04/2012 Version 2” stipulated “The patient has the right to- 1. Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD ... Patient rights and the ability to exercise these rights must be protected by the facility.” During interview with the Senior Regulatory Manager on 11/09/2023 beginning at 1500, they stated that they were “not in the loop at all” regarding the complaints made against the RN in January and March. They also stated the expectation would be for the ATL to document any actions taken against the RN regarding the complaints.”

“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: 31224 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 treatment and monitoring for 4 of 5 patients (Patients #s 2, 3, 4 and 5). Findings: 1. Review of Patient #2’s dialysis orders and treatment sheets dated, 08/01/2023 through 08/26/2023 revealed: * The treatment sheets reflected the following: - On 08/08/2023, the treatment sheet reflected orders for “BFR: 400.” At 1524, a PCT documented starting treatment with the BFR set to 450, which remained for the entire treatment with no documentation as to why the order was not followed, no RN notification and no RN follow-up. - On 08/12/2023, the treatment sheet reflected orders for “BFR: 400.” At 1501, a RN initiated treatment with the BFR set at 300. A PCT changed the BFR during treatment to 350 and back to 300. There was no documentation by the RN stating why the order was not followed or by the PCT to notify the RN of changes. * Treatment sheets dated 08/17/2023, 08/19/2023, and 08/26/2023 reflected similar findings. - On 08/03/2023, the treatment sheet reflected Patient #2 had elevated blood pressure readings. For example, Patient #2’s blood pressure was documented as 182/100 at 1707 and increased to as high as 201/111 at 1833. There was no documentation to indicate the PCT notified the RN or LVN of the elevated blood pressure. At 1951, a LVN stopped treatment and the blood pressure was 196/110. There was no documentation to indicate the LVN notified the RN of the elevated blood pressure. At 2017, the RN documented, “Treatment completed...BP WNL.” There was no follow up addressing the elevated BP documented by the RN prior to sending the patient home. * Treatment sheets dated 08/08/2023, 08/12/2023, 08/12/2023, 08/15/2023, 08/17/2023, and 08/26/2023 reflected similar findings. 2. Review of Patient #3’s dialysis orders and treatment sheets dated 08/18/2023 through 08/30/2023 revealed. * The treatment sheets reflected the following: - On 08/23/2023, the treatment sheet reflected orders for “BFR: 300.” At 0648, a PCT initiated treatment with the BFR set to 350, which remained for the entire treatment with no documentation as to why the order was not followed, no RN notification and no RN follow-up. Additionally, the PCT noted Patient #3’s diastolic BP measured 103 at 0648 and remained greater than 100 for most of the dialysis treatment. At 0749, the RN noted Patient #3’s diastolic BP measured 104. The diastolic BP was over 100 for most of the treatment with no documentation to indicate the RN was concerned or addressed the elevated blood pressure. At 1148, the RN documented, “No Unusual findings noted” and the patient was discharged to home. * Treatment sheet dated 08/25/23 reflected similar findings. * Similar findings were noted for Patient #s 4 and 5. * Review of the facility policy, “Patient Assessment and Monitoring,” dated as “09/29/2018 Version: 3” stipulated in the section titled “Monitoring During Treatment” that “Document machine parameters and safety checks every 30 [minutes] or more often as needed but not to exceed 45 minutes or per state regulations ... Step 1 ... Blood Pressure ... Record blood pressure ... Report to the nurse ... Diastolic blood pressure greater than 100 mm/Hg Step] 3 ... Machine Parameters and Extracorporeal Circuit ... Check machine setting and measurements ... Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow.” During interview on 08/31/2023 at 1605, the FA 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: 37237 Based on interview, review of patient immunization documentation and review of facility policies and procedures, it was determined that the facility failed to offer pneumococcal vaccinations to patients based on assessment of status as required by facility policy. Findings: Review of the “Pneumonia Vaccination Report,” printed on 08/29/2023 revealed 19 of 48 patients had “08/29/2023” entered in the “Next Due Date” column. The “Suggested Action(s)” column for all 19 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. Review of the facility policy titled, “Pneumococcal Vaccine for Adults,” dated “07/05/2022 Version: 5” 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 October 2021. During interview with the DO on 08/31/2023 at 1100, the above findings were presented. The DO 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-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 the review of documentation it was determined the facility failed to ensure all staff met the personnel qualifications and demonstrated competencies necessary to meet the comprehensive care needs of the patients. Findings: The review of documentation included the “Personnel Audit Tool-ESRD” worksheet, completed and emailed by the FA on 10/18/2023. The Personnel Audit Tool revealed: * Staff #2 was identified as a PCT with no hire date listed. The worksheet failed to list a date for annual Emergency Procedures training. * Staff #18 was identified as a PCT with a DOH of 04/16/2023. The worksheet listed the most recent water dialysate training was completed on 02/03/2024. * Staff #23 was identified as the FA with a DOH of 07/15/2015. The worksheet listed the most recent annual competencies and skills trainings were completed on 08/05/2022. * Staff # 24 was identified as an RN with a DOH of 03/24/2021. The worksheet listed the annual Emergency Procedures training was completed on 07/07/2022. * Staff #25 was identified as an RN with a DOH of 10/30/2022. The worksheet listed the annual competencies and skills trainings were completed on 04/08/2022 and the annual water dialysate training was completed as 08/22/2022. * Staff #29 was identified as an RN with no hire date listed. The worksheet failed to list a date for annual Emergency Procedures training. * Staff #30 was identified as an RN with a DOH of 05/04/2020. The worksheet listed annual water dialysate training was last completed during 2020. The month listed was illegible. * Staff # 31 Was not listed on the personnel list. Refer to findings identified in tag V260. * Staff #33 Was not listed on the personnel list. Refer to findings identified in tag V452.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 37237 Based on interview and review of documentation, it was determined that the facility failed to implement and evaluate an effective internal grievance process. Findings: Review of the facility’s grievance/complaint log from 01/01/2023 to 08/29/2023, presented for review, revealed no grievances/complaints were documented for 2023. During interview with the facility ATL on 08/29/2023 at approximately 1400, they confirmed that no grievances/complaints were documented for 2023. Review of the facility policy titled, “Patient Grievance Procedure,” dated “04/04/2014 Version: 3” stipulated “Follow the steps below when a patient or patient representative has a grievance ... 5. The CM ensures the following details are completed in the Quality Assessment and Performance Improvement (QAI) Patient Grievance Status Report: Date grievance received; Mode of grievance (i.e. meeting, phone call, email, letter, fax); Intake Person; Patient Initials; Nature of the grievance; Findings of the investigation; Grievance referred to (if any); Resolution and any corrective actions taken; Any follow-up related to the grievance. Note: Even if a patient’s grievance is resolved quickly, the CM must document the complaint and the actions taken to resolve it. 6. The CM ensures that all patient grievances are reported to the QAI Committee.””

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 37237 Based on interview, review of facility personnel files, review of patients’ medical records, review of policies and procedures and review of the facility’s Emergency Preparedness binder, it was determined the facility failed to comply with the Federal Emergency Preparedness (EP) requirement to maintain a comprehensive EP program, 42 CFR § 494.62 - Condition of participation: Emergency preparedness. This condition-level deficiency substantially limits the capacity of the facility to furnish services of an adequate level of quality. Findings: The facility failed to maintain a comprehensive EP program, as evidenced by the following: 1. Complete an annual hazard and vulnerability assessment. The last date for completion was 01/01/2022. 2. Implement an Emergency Preparedness Training and Testing program: * The clinic failed to provide documentation of participation in any community or table top emergency exercises since 2020; * The clinic failed to document whether all patients received emergency preparedness or emergency procedure training. 3. Patient contact information was outdated or missing. * Pediatric patient list was dated 07/2022. * No adult patient contact list was found in the EP or crash cart binders. 4. Facility emergency contact information was last updated in 04/2021 and was outdated. 5. The Emergency Information Directory with staff contact information was last revised in 08/02/2017 in the emergency cart binder or 07/01/2022 in the emergency preparedness binder and was outdated. 6. Annual letters to the local emergency preparedness agency and other emergency preparedness collaborators were last sent in 11/2021. 7. On 08/29/2023 at 1040, the adult crash cart was observed unlocked, which left the medications unsecured. 8. The pediatric crash cart was observed to have expired medications, including: * 10 vials of naloxone dated 02/2023. * 4 vials of adrenalin dated 07/2023. * 2 vials of naloxone dated 07/2023. * 2 vials of diphenhydramine dated 07/2023. During interview on 08/29/2023 at 1045, the DO confirmed findings #7 and 8. During interview on 08/29/2023 at 1100, the FA confirmed findings #1-6.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 37237 Based on observations, interviews and review of documentation, it was determined that the Governing Body failed to: - Ensure the care and safety of patients; - Ensure all patients were treated with respect and dignity; and - The Emergency Preparedness plan was current and that patient and staff contact information was up-to-date. - Ensure the internal grievance process was followed. This condition-level deficiency substantially limits the capacity of the facility to furnish services of an adequate level of quality. Findings: Refer to findings identified in tags V110, V450, V765 and E003.”

“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, interview and review of facility policies, it was determined the facility failed to provide and monitor a sanitary environment to minimize the transmission of infectious agents within the dialysis unit. Findings: During observation of the facility on 08/29/2023 at 1010, a PCT was giving care in and out of a patient’s treatment area on the general dialysis treatment floor. At 1020 this surveyor initiated a conversation with this patient. During the conversation, the patient told the surveyor that they tested positive for COVID-19 that morning. Both the PCT and the patient were wearing a surgical mask. The PCT was working and moving between 3 patients within the pod. The surveyor asked the FA if they were aware of the patient with COVID-19. The FA stated they were not aware that any of the patients currently had COVID-19. At approximately 1100, the FA stated that the PCT had not been told the patient was COVID-19 positive, but the RN was aware. Review of the facility policy, “Guidance on Dialyzing and Infection Control Practices of COVID-19 in Fresenius Kidney Care (FKC) Dialysis Clinics,” dated as “Published 05/19/2023 ... Version 4” stipulated on page 7 in the section titled “Cohorting COVID-19, PUI and CCE Patients” that “COVID-19 positive patient may be cohorted and treated within their home clinic treatment shift with appropriate infection control precautions in place. When COVID-19 positive, PUI or CCE patients are being treated within the home clinic or program, the patient should be masked with an N95 respirator mask and treated at a corner or end-of-row station away from the main flow of clinic traffic ... Each classification of patients (i.e., COVID-19 positive, PUI, and CCE) must be cohorted in distinct locations on the treatment floor and classifications of patients should not be intermingled with each other ... FKC staff members who are directly caring for PUI, or COVID-19 patients must wear gown, gloves, face shield and an N95 respirator mask ... Take precautions to avoid crossover and intermingling of COVID-19 positive and PUI patients with negative patients ... When possible, there should be dedicated staff for PUI and COVID-19 positive cohorts with no crossover to provide care to asymptomatic and COVID-19 negative patients. If there are shared staff members between the PUI and COVID-19 classifications and negative patients, the staff member must wear dedicated PPE in caring for the COVID-19 positive and PUI patients.””

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 37237 Based on interview and review of documentation, it was determined that the facility failed to ensure that HBV serological tests were drawn and that the hepatitis status of susceptible patients were monitored in order to manage care appropriately. Findings: Review of the facility’s “Hepatitis B Summary Report,” created “08/29/2023,” that included documentation of Hepatitis B vaccination status of 48 patients, revealed 13 of 48 patients with HBsAb less than 10 failed to have monthly ABsAg monitoring documented. Review of the facility policy titled, “Patient Hepatitis B Testing Requirements,” dated as “Published 01/07/2022 ... Version: 2” stipulated in the section “HBV Patient Testing” that monthly HBsAg testing is required when a patient is determined “Susceptible ... Anti-HBs: less than 10mlU/ml.” During interview with the DO on 08/31/2023 at 1100, the above findings were presented. Detailed information was discussed with the DO and the above findings were confirmed.”

“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: 37237 Citation Text for Tag 0126, Regulation FV12 McDowell, Janis S. Based on interview and review of documentation, it was determined the facility failed to ensure that all susceptible patients were offered vaccination against Hepatitis B. Findings: Review of the facility’s “Hepatitis B Summary Report,” created “08/29/2023,” that included documentation of Hepatitis B vaccination status of 48 patients revealed 15 patients who were determined susceptible lacked documentation of receiving the vaccine series, the vaccine series was incomplete or the vaccine series was incorrectly administered. Review of the facility policy titled, “Patient Vaccination for Hepatitis B,” dated “02/07/2022 ... Version: 5” stipulated “The Hepatitis B vaccine shall be offered to all susceptible patients including peritoneal and home dialysis patients.” The policy provided guidelines for offering vaccination series or booster doses. During interview with the DO on 08/31/2023 at 1100, the above findings were presented. Detailed information was discussed with the DO and the above findings were 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 and review of documentation, it was determined that the facility failed to ensure that all employees responsible for operating, testing and monitoring the water and dialysate systems completed the required training and annual skills checks required by facility policy and this regulation. Findings: Review of the facility’s digital Hourly TCL Logs for June 2023 and July 2023 revealed: * On 06/13/2023, the “1339” reading was “Confirmed By” Staff #31. Similar findings on 06/15/2023, 06/17/2023 and 06/20/2023 were identified. * On 07/11/2023, the “0744” and “1038” readings were “Confirmed By” Staff #31. In an email dated 09/27/2023, the ATL reported Staff #31 completed the required training on 09/01/2023 and confirmed they had not completed the water room skills check off prior to conducting the above checks. Failure by the facility to ensure that all staff had received the required water room training could result in the contamination of the water system and/or incorrectly mixed dialysate. Exposure to contaminated water or incorrectly prepared dialysate could potentially result in serious negative effects for the patients, including but not limited to, pyrogenic reactions, bacteremia and serum electrolyte imbalance and subsequent complications.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 37237 Based on observation and interview, it was determined the facility failed to ensure the dialysis facility was maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. Findings: Observations of the facility on 08/29/2023 included, but were not limited to: 1. Physical Environment * A two-wheeled bicycle was parked in the middle of the treatment floor. * Dry, white precipitate on the front of cabinet drawers in clean prep areas, on garbage cans and on biohazard cans. * Trash on the floor near several patient stations and in common walk areas, including but not limited to food wrappers and used gloves. * Arm pillows for patient chairs found on the floor between patient stations. * Throughout the treatment floor, items were stored behind the machines on the wall boxes. Items included, but not limited to jugs of Citrasate, patient chair arm pillows, clothing, and ancillary equipment. * Several wall boxes contained a white precipitate. * A plastic jug containing an unknown liquid, which lacked a lid, was stored behind a patient station. * A sink labeled as “Dirty” had soap and a paper towel dispenser available for use. A dirty sink is designed to use primarily for disposal and not cleaning. A sink with soap and paper towels available for use could easily be mistaken for a handwashing sink. 2. Expired items/medications * An opened MDV of Heparin Sodium Injection 30,000 USP Units/30 mL lacked an opened date, BUD, and initials of the person who opened it. * An opened 2 mL vial of Lidocaine 1% lacked an opened date, BUD, and initials of the person who opened it. * 29 3-packs of Povidone-Iodine swab stick applicators had an expiration date of October 2022. * Two single-packs of Povidone-Iodine swab stick applicators had an expiration date of July 2023. * An opened bottle of “WaterCheck Residual Chlorine” reagent strips lacked an opened date. The bottle is clearly marked, “Use within 3 months after opened.” * A package of 2.7 mL blue-topped blood collection tubes expired 07/31/2023. * Four single-dose prefilled syringes of “Influenza Vaccine Fluzone High-Dose Quadrivalent” vaccine with an expiration date of 06/30/2023. * An opened MDV of Tuberculin Purified Protein Derivative (Mantoux) lacked an open date, BUD and initials of the person who opened it. It was labeled “opened 7-27” outside of the box package. Without a full date, the expiration date is unable to be determined. * An opened MDV of Tuberculin Purified Protein Derivative (Mantoux) had a handwritten note “opened 7/10/23 Exp 8/9/23 SK.” * Two unopened vials of Adrenalin 1mg/mL expired on 07/2023. * Two unopened vials of Naloxone 0.4mg/mL expired on 07/2023. * An opened bottle of “Mesa Lab Standard Buffer Solution 10.00 pH” lacked an opened date. Clearly marked on the front of the solution bottle, “Discard 90 days after opening.” * Two 32-oz containers of LiquaCel Grape Concentrated Liquid Protein expired May 2023. * One 32-oz container of LiquaCel Peach Mango Concentrated Liquid Protein expired January 2023. * One 32-oz container of LiquaCel Peach Mango Concentrated Liquid Protein expired June 2023. * Two boxes of 25-count Providone-Iodine swab sticks expired 10/2022. * Six boxes of 50-count transparent dressings: 1 box expired 03/2023, 1 box expired 05/2023, and 4 boxes expired 06/2023. * One box of Durapore tape expired 08/13/2023. * Five bottles of “SteriChek Sensitive Low-Range Water Hardness Reagent Strips” were expired: 1 bottle expired 01/2023, 3 bottles expired 03/2023, and 1 bottle expired 04/2023. On 08/29/23 at approximately 1035, a staff member was asked why the bicycle was parked on the treatment floor when there was a designated bicycle parking area outside of the lobby area and they stated, “I have no idea why that is there.” Review of current CDC guidelines for “Injection Safety” stipulated “If a multi-dose vial has been opened or accessed (e.g. needle-punctured), the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.” During an interview with the FA on 08/29/2023 at 1155 and at approximately 1600, the above findings were confirmed.”

“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 and the review of documentation, it was determined that the facility failed to ensure that all equipment was maintained and operated in accordance with the manufacture’s recommendations. Findings: Review of the facility’s digital logs for May 2023 through August 2023 revealed: “Helmer Medication Refrigerator Log” - May 2023: * On 05/09/2023, no PM temperature was recorded; and * On 05/25/2023, no PM temperature was recorded; - June 2023 * On 06/05/2023, the PM temperature was recorded at “0414;” and * On 06/20/2023, the AM temperature was recorded at “1923.” “Glucose Meter Log” - May 2023 * Missing entry for 05/23/2023. - June 2023 * On 06/28/2023, the “Test Strip Expiration Date” was entered as “06/15/2023;” and * On 06/06/2023, the “90-days Expiration Control 2” was entered as “06/06/2023.” - July 2023 * Missing entry for 07/06/2023; * On 07/19/2023, the “Test Strip Expiration Date” was entered as “07/19/2023;” and * On 07/22/2023, the “Test Strip Low Range” was “92-124”. The value of “125” was documented as the “Low Result” without any note indicating any action was taken due to the out of range result. “AED - Zoll (Daily) Log” - June 2023 * Missing entries on 06/08/2023, 06/10/2023, 06/13/2023, 06/20/2023. “Hourly TCL Log” - May 2023 * On 05/11/2023, the “0520” hourly reading was completed late at “0609,” after patients had their hemodialysis initiated; * On 05/20/2023, the “0520” hourly reading was completed late at “0531;” and * On 05/30/2023, the “1811” hourly reading was completed late at “1832.” - June 2023 * On 06/13/2023, the reading was “Confirmed By” Staff #31. An email discussion with the ATL on 09/27/2023 confirmed Staff #31 had not completed a water room skills check-off prior to the survey. Similar findings were identified for 06/15/2023, 06/17/2023 and 06/20/2023. - July 2023 * On 07/11/2023, the “0744” reading was “Confirmed By” Staff #31 who failed to have a water room skills check-off completed. Similar reading at “1038” were found; and * On 07/29/2023, the “1629” hourly reading was completed late at “1638.” “2% Citric Acid Container Solution Mixing Log” - May 2023 * Missing entries on 05/01/2023, 05/03/2023, 05/05/2023, 05/06/2023, 05/08/2023, 05/17/2023, 05/18/2023 and 05/19/2023. * On 05/23/2023, the “Packet Use By Date” was entered as “10/01/01.” - June 2023 * Missing entry on 06/15/2023. - August 2023 * Missing entries for 08/10/2023, 08/14/2023, 08/25/2023, 08/26/2023 and 08/28/2023. “Storage Room Temperature Log” for Room #1 - May 2023 * On 05/13/2023, “0459” was entered instead of a temperature; * On 05/16/2023, “0500” was entered instead of a temperature; * On 05/18/2023, “0450” was entered instead of a temperature; * On 05/25/2023, “0500” was entered instead of a temperature; and * On 05/30/2023, “0455” was entered instead of a temperature. - June 2023 * On 06/01/2023, “0459” was entered instead of a temperature; * On 06/03/2023, “0500” was entered instead of a temperature; * On 06/06/2023, “0455” was entered instead of a temperature; * On 06/08/2023, “0500” was entered instead of a temperature; * On 06/10/2023, “0500” was entered instead of a temperature; and * On 06/15/2023, “0500” was entered instead of a temperature. “O2 Concentrator (Weekly) Log” - July 2023 Documentation on 07/29/2023 revealed staff failed to clean the oxygen concentrator filters on 10 of 15 machines. - August 2023 Documentation on 09/19/2023 revealed staff failed to clean the oxygen concentrator filters on 4 of 15 machines. Review of the “Daily Patient Schedule” revealed that patients start their hemodialysis treatment at 0520 on the TTS shift.”

“PR-RESPECT & DIGNITY CFR(s): 494.70(a)(1) The patient has the right to- (1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD This Standard is not met as evidenced by: 37237 Based on interview and the review of documentation. it was determined the facility failed to ensure the patients’ right to be treated with respect and dignity. Findings: Staff #33 All personnel documentation for Staff #33 was received via email from FMC on 11/08/2023. Review of the personnel “Job Data” file revealed that Staff #33 was terminated effective 08/26/2023 for “Inv-Violation of Policies.” Review of the performance review for “Performance Year: 2021” revealed in the “Goals” section that “Goal Title ... Stay focused and prioritize [your] tasks. Expected Result ... Continue to be less distracted and prioritize tasks. Make less (sic) mistakes, ie (sic): entering incorrect treatment information, hours, etc. Double check all work before leaving station ... Manager comments: The mistakes continue to occur. Incorrect treatment time or goal are noted at times, incorrect med drawn up, etc. Fortunately, [Staff 33] or a staff member find it before it becomes an issue or problem. Needs to clarify treatment notes to reflect actions done for high/low Vital Signs. It is so important to document these interventions and the follow up.” The performance review lacked a manager’s signature and lacked any employee comments, self-ratings or signature. It could not be determined from the documentation presented if the evaluation with the goal expectations was discussed or reviewed with Staff #33. Review of the performance review for “Performance Year: 2022.” revealed nothing was documented in the “Goals” section. In the section titled “Overall” it was documented “Manager Overall Final rating 4 - Needs improvement ... Areas for improvement [Staff #33] needs to take time to do the eCube Master class ... also needs to also be aware of policies and procedures in place.” The performance review lacked a dated signature from the employee and the manager. In the section for signatures, “False” is listed for both. The performance review also lacked any employee comments or self-ratings. It could not be determined from the documentation presented if the goals outlined in the 2021 performance review were met and if the 2022 evaluation was discussed or reviewed with Staff #33. Review of Staff #33’s learning transcripts revealed the last eCube training was completed on 8/16/2017. Further review of Staff #33’s education and training revealed: The last “Annual Compliance Training” was completed 11/01/2021. The last “Annual Clinical Skills Validation and Exam for RNs” was completed 06/20/2022. The last “Annual Water Training” was completed 03/10/2022. Review of the “Outpatient CAP RN 2” job description signed by Staff #33 on 03/01/2019 revealed “The CAP RN 2 is accountable and responsible for the provision and coordination of clinically competent care including assessment, planning, intervention and evaluation for an assigned group of patients ... Serves as a leader, coach, mentor and role model for new and incumbent employees by setting examples of appropriate behavior, work habits and attitudes towards patients, co-workers, supervisors and the company at the facility and area level.” In the “Experience and Required Skills” section, the job description stipulated “Successful completion of all annual required education/training/competencies ... Successful completion of on-going training and education as assigned or required.” No further documentation was provided to ensure Staff #33 was trained, educated, coached or put on a performance plan to improve or meet overall expectations outlined in the “Outpatient CAP RN 2” job description. Review of personnel documentation provided by FMC on 11/08/2023 revealed an email sent to the ATL by Staff #34 on 01/25/2023. The subject of the email was “Inappropriate situation with [Staff #33]” Staff #34 wrote “I’m reaching out because we had an incident between [Staff #33] and [Patient 1] today ... [Staff #33] was assessing [Patient 1] and then asked for a hug. [Patient 1] said ‘no’ and [Staff #33] proceeded to go in for a hug after which [Patient 1] said ‘no’ again. [Staff #33] said something to the effect of ‘oh, come on it’s fine.’ [Patient 1] then firmly, and clearly uncomfortable said, ‘no means no’. [Staff #33] then said ... ‘Well, I tried ... you had your chance.’ [Patient 1] responded by saying ‘I didn’t want a chance’. [Staff #33] continued to say multiple times to [Patient 1] that [they] ‘hurt [Staff #33’s] feelings.’” Review of personnel documentation provided by FMC on 11/08/2023 revealed an email sent to the ATL by Staff #35 on 03/03/2023. A pediatric nephrologist was cc’d. The subject of the email was “Situations and Concerns this week in Pediatrics.” Staff #35 wrote “Monday was [Patient 2’s] first treatment ... [They are] very good about staying still and not moving [their] arm at all during blood pressures. At one point ... [another staff] and I heard [them] whining and fussing. [Staff #33] was holding [their] harm [sic] quite firmly, upsetting [them]. [Patient 2] was then crying and upset through the rest of the treatment ... Wednesday, it happened again. [Patient 2] was fine and calm and ... had suddenly got worked up and was crying. [Staff #33] was over there firmly holding [them] down during [their] blood pressure ... [Staff #33] then firmly stated ‘well [they] are new and [Patient 2] is gonna (sic) to learn!’ [Patient 2] is 3 years old ... I told [Staff #33] it’s just not necessary to restrain [their] or hold [their] arm ...” The email also listed numerous situations where the RN was unable to perform tasks to standard, i.e. “Multiple times a day, we have to have the same exact conversation yet there is no understanding ... We have to ask for a second verification and assessments multiple times and still will not get one.” And “There has been some upsetting comments towards [Patient 3] regarding unclamping [their] CVC ... Today [Staff #33] came up and said ‘Two and a half years [Patient 3] and nothing has changed. Its (sic) like you don’t even care do you? You don’t care on what happens to you ...’” Also “About a month ago, [Staff #33] told [Patient 3] ‘Every morning I wonder if you are going to be alive or if you bleed (sic) to death because you just don’t care.’ ... this seems to be really negatively impact (sic) [Patient 3] and doesn’t seem beneficial.” Review of the Human Resources document “Corrective Action Form” for [Staff # 33] presented by FMC via email on 11/08/2023 revealed “List all applicable date(s) for this incident/occurrence ... 8/9/2023.” Under the “Reason for corrective action” the form lists “Violation of Behavior in the Workplace policy ... Violation of Core Values ... Violation of Patient Rights and Responsibilities.” Also listed under “Reason for corrective action” was “On August 11, 2023, a complaint was received regarding interaction [Staff #33] had with a pediatric patient. Investigation findings revealed that on August 9, 2023 [Staff #33] failed to respect professional boundaries in an interaction with a pediatric patient. In January 2023, [Staff #33] was coached and reminded of expectations concerning professional boundaries.” In the section of the form “Current Corrective Action” the only box checked was “Level 3 - Termination of Employment.” The Corrective Action Form was signed by the RVP and Lead ER Mgr and dated 08/25/2023. Review of the document, “Case: FMCNA-2023-8-8079-Compliance Action Line - Web HR Harassment / Discrimination,” section “Case Details” revealed “Is management aware of your concern? Yes ... If yes, then who? ... I was uncomfortable going to our direct management due to a recent issue of our manager breaking confidentiality of a concern with this particular RN ... So I went to my Medical director and [they were] going to reach out to my FA and ATL. [The Medical Director] told me to file this report right away.” Written under “Details: We have an RN that has had a history of pushing the boundaries with our pediatric patients physically. In this event, [they] asked if [they] get a kiss from one of our pediatric patients ... [They] proceeded to kiss [them] on the lips (with masks on both). This particular Child is the age of 6 BUT with the mental capacity and the size of a toddler/18month old ... My medical director told me I should make aware this is not the first incident... I had reported this to management in an email. I am extremely concerned that after [Staff #33] is talked to, this could create a very awkward and hostile environment. I was the only person present and [they] will know I am the one who spoke up.” From the review of the documentation provided, the facility failed to take action against the RN prior to the complaint filed to the corporate office. The facility failed to provide any other documentation of corrective actions taken regarding the complaints to the ATL dated 01/25/2023 and 03/03/2023. Documentation of education, coaching, or training of expectations concerning professional boundaries was not provided. Review of the facility policy, “Patient Rights and Responsibilities,” dated as last revised “04/04/2012 Version 2” stipulated “The patient has the right to- 1. Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD ... Patient rights and the ability to exercise these rights must be protected by the facility.” During interview with the Senior Regulatory Manager on 11/09/2023 beginning at 1500, they stated that they were “not in the loop at all” regarding the complaints made against the RN in January and March. They also stated the expectation would be for the ATL to document any actions taken against the RN regarding the complaints.”

“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 treatment and monitoring for 4 of 5 patients (Patients #s 2, 3, 4 and 5). Findings: 1. Review of Patient #2’s dialysis orders and treatment sheets dated, 08/01/2023 through 08/26/2023, were reviewed. * The treatment sheets reflected the following: - On 08/08/2023, the treatment sheet reflected orders for “BFR: 400.” At 1524, a PCT documented starting treatment with the BFR set to 450, which remained for the entire treatment with no documentation as to why the order was not followed, no RN notification and no RN follow-up. - On 08/12/2023, the treatment sheet reflected orders for “BFR: 400.” At 1501, a RN initiated treatment with the BFR set at 300. A PCT changed the BFR during treatment to 350 and back to 300. There was no documentation by the RN stating why the order was not followed or by the PCT to notify the RN of changes. * Treatment sheets dated 08/17/2023, 08/19/2023, and 08/26/2023 reflected similar findings. - On 08/03/2023, the treatment sheet reflected Patient #2 had elevated blood pressure readings. For example, Patient #2’s blood pressure was documented as 182/100 at 1707 and increased to as high as 201/111 at 1833. There was no documentation to indicate the PCT notified the RN or LVN of the elevated blood pressure. At 1951, a LVN stopped treatment and the blood pressure was 196/110. There was no documentation to indicate the LVN notified the RN of the elevated blood pressure. At 2017, the RN documented, “Treatment completed...BP WNL.” There was no follow up addressing the elevated BP documented by the RN prior to sending the patient home. * Treatment sheets dated 08/08/2023, 08/12/2023, 08/12/2023, 08/15/2023, 08/17/2023, and 08/26/2023 reflected similar findings. 2. Review of Patient #3’s dialysis orders and treatment sheets dated 08/18/2023 through 08/30/2023 were reviewed. * The treatment sheets reflected the following: - On 08/23/2023, the treatment sheet reflected orders for “BFR: 300.” At 0648, a PCT initiated treatment with the BFR set to 350, which remained for the entire treatment with no documentation as to why the order was not followed, no RN notification and no RN follow-up. Additionally, the PCT noted Patient #3’s diastolic BP measured 103 at 0648 and remained greater than 100 for most of the dialysis treatment. At 0749, the RN noted Patient #3’s diastolic BP measured 104. The diastolic BP was over 100 for most of the treatment with no documentation to indicate the RN was aware or addressed the elevated blood pressure. At 1148, the RN documented, “No Unusual findings noted” and the patient was discharged to home. * Treatment sheet dated 08/25/23 reflected similar findings. * Similar findings were noted for Patient #s 4 and 5. * Review of the facility policy, “Patient Assessment and Monitoring,” dated as “09/29/2018 Version: 3” stipulated in the section titled “Monitoring During Treatment” that “Document machine parameters and safety checks every 30 [minutes] or more often as needed but not to exceed 45 minutes or per state regulations ... Step 1 ... Blood Pressure ... Record blood pressure ... Report to the nurse ... Diastolic blood pressure greater than 100 mm/Hg Step] 3 ... Machine Parameters and Extracorporeal Circuit ... Check machine setting an measurements ... Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow.” During interview on 08/31/2023 at 1605, the FA 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: 37237 Based on interview, review of patient immunization documentation and review of facility policies and procedures, it was determined that the facility failed to offer pneumococcal vaccinations to patients based on assessment of status as required by facility policy. Findings: Review of the “Pneumonia Vaccination Report,” printed on 08/29/2023 revealed 19 of 48 patients had “08/29/2023” entered in the “Next Due Date” column. The “Suggested Action(s)” column for all 19 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. Review of the facility policy titled, “Pneumococcal Vaccine for Adults,” dated “07/05/2022 Version: 5” 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 October 2021. During interview with the DO on 08/31/2023 at 1100, the above findings were presented. The DO 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-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 the review of documentation it was determined the facility failed to ensure all staff met the personnel qualifications and demonstrated competencies necessary to meet the comprehensive care needs of the patients. Findings: The review of documentation included the “Personnel Audit Tool-ESRD” worksheet, completed and emailed by FA on 10/18/2023. The Personnel Audit Tool revealed: * Staff #2 was identified as a PCT with no hire date listed. The worksheet failed to list a date for annual Emergency Procedures training. * Staff #18 was identified as a PCT with a DOH of 04/16/2023. The worksheet listed the most recent water dialysate training was completed on 02/03/2024. * Staff #23 was identified as the FA with a DOH of 07/15/2015. The worksheet listed the most recent annual competencies and skills trainings were completed on 08/05/2022. * Staff # 24 was identified as an RN with a DOH of 03/24/2021. The worksheet listed the annual Emergency Procedures training was completed on 07/07/2022. * Staff #25 was identified as an RN with a DOH of 10/30/2022. The worksheet listed the annual competencies and skills trainings were completed on 04/08/2022 and the annual water dialysate training was completed as 08/22/2022. * Staff #29 was identified as an RN with no hire date listed The worksheet failed to list a date for annual Emergency Procedures training. * Staff #30 was identified as an RN with a DOH of 05/04/2020. The worksheet listed annual water dialysate training was last completed during 2020. The month listed was illegible. * Staff # 31 Was not listed on the personnel list. Refer to findings identified in tag V240. * Staff #33 Was not listed on the personnel list. Refer to findings identified in tag V452.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 37237 Based on interview and review of documentation, it was determined that the facility failed to implement and evaluate an effective internal grievance process. Findings: Review of the facility’s grievance/complaint log from 01/01/2023 to 08/29/2023, presented for review, revealed no grievances/complaints were documented for 2023. During interview with the facility ATL on 08/29/2023 at approximately 1400, they confirmed that no grievances/complaints were documented for 2023. Review of complaint documentation received by the State Agency revealed at least one complaint allegation had been communicated to the facility in 2023. Review of the facility policy titled, “Patient Grievance Procedure,” dated “04/04/2014 Version: 3” stipulated “Follow the steps below when a patient or patient representative has a grievance ... 5. The CM ensures the following details are completed in the Quality Assessment and Performance Improvement (QAI) Patient Grievance Status Report: Date grievance received; Mode of grievance (i.e. meeting, phone call, email, letter, fax); Intake Person; Patient Initials; Nature of the grievance; Findings of the investigation; Grievance referred to (if any); Resolution and any corrective actions taken; Any follow-up related to the grievance. Note: Even if a patient’s grievance is resolved quickly, the CM must document the complaint and the actions taken to resolve it. 6. The CM ensures that all patient grievances are reported to the QAI Committee.””