Davita Garfield Kidney Center

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 34411 Based on document review, observation, and interview, it was determined that for 1 of 1 emergency cart, the Facility failed to ensure that emergency medications were readily available for use. Findings include: 1. The Facility’s policy titled, “Emergency Equipment Checks” (dated 4/2022), was reviewed, and required, “...emergency drugs will be on the premises at all times. Recommended emergency medications to stock in the facility are medications to treat...anaphylactic reactions, hypoglycemia [low blood sugar] ...” 2. The Facility’s Medical Expiration Log, was reviewed and did not include medications that would treat anaphylactic reactions or hypoglycemia. 3. On 11/14/2023 at 9:15 AM, an observational tour of the dialysis treatment area was conducted. During the tour, the emergency cart was checked with the Staff RN (E #4). The cart lacked any medications for anaphylactic reaction or hypoglycemia. The medication cabinets also lacked these medications. 4. On 11/14/2023 at 9:25 AM, an interview was conducted with E #4. E #4 stated that the Facility does not carry emergency medications and that they just call 911. 5. On 11/14/2023 at 2:30 PM, an interview was conducted with the Clinical Coordinator (E #2). E #2 stated that the clinic does carry some emergency medications. E #2 stated that, however, they do not have medication for anaphylactic shock or hypoglycemia, as they should.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 34411 Based on document review, observation, and interview, it was determined that for 2 of 3 staff observed (E#7, E #8), the Facility failed to ensure that pH (measure of acidity/alkalinity) testing was conducted according to the manufacturer’s instructions for use (IFU) and policy. This had the potential to affect all in-center dialysis patients as of 11/14/2023. Findings include: 1. The Facility’s procedure titled, “Testing pH of Citric Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8-8.5 Test Strips” (dated October 2020), was reviewed and required, “2. Obtain dialysate sample by using a disposable cup, then dip the strip in the solution for one (1) second. Or using new syringe, obtain dialysate sample from sample port, then allow fluid to flow over the pad for one (1) second. 3. Remove the strip from the fluid and shake off excess dialysate. 4. At 10 seconds, immediately compare the color reaction on strip to the color chart on bottle to determine the closest match...” 2. The RPC E-Z Chek K100-0117CT manufacturer’s “Important Application Note” (undated), was reviewed and required, “...Read carefully, the entire instructions for use (IFUs)... For every test, use a stop watch or second hand of a clock/watch to make sure the dip/swish time and wait time called for in the IFUs is correct. Proper test sample exposure time and wait time are critical for test strip accuracy...” 3. During a tour of the dialysis treatment area on 11/14/2023, the following was observed: - At approximately 9:50 AM, at station #3, a Patient Care Technician /PCT (E#8), obtained a sample of dialysate. E#8 dipped the pH test strip into the sample and read the test strip immediately. E #8 stated that they should wait 15 seconds (not the required 10 seconds). E #8 stated that E #8 counted in her head. E #8 stated that the pH of the dialysate should be 7.8 (not the designated range of 6.9-7.6). - At approximately 9:55 AM, at station #16, a PCT (E#7), obtained a sample of dialysate from the wall box behind the machine. E#7 then dipped the pH test strip into the sample and read the test strip immediately. E #7 then verbalized that the strip should be read at 15 seconds (not the required 10 seconds). 4. On 11/16/2023 at approximately 11:00 AM, an interview was conducted with a PCT (E #6). E #6 stated that dialysate sample should be only taken from the machine and not the wall box. E #6 stated that after the sample is obtained, they should wait 10 seconds. E #6 stated the pH range is 6.9-7.6.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 40079 Based on document review and interview, it was determined that the Facility failed to ensure that for 4 of 8 (Pt # 4, Pt #5, Pt #6, Pt #7) clinical records reviewed for post dialysis weight, the Facility failed to address the post dialysis target weight not met to ensure the volume status was managed as required. Findings include: 1. The Facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” (revised 10/2023) was reviewed and required, “...11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately ... 13. All findings, interventions and patient response will be documented in the patient’s medical record ... Abnormal findings: Fluid status ... Post treatment: if patient is above or below 1 kg (kilogram) form the target weight.” 2. The clinical record of Pt. #4’s was reviewed. Pt. #4 was admitted to the Facility on 10/16/19 with a diagnosis of end stage renal disease (ESRD). The clinical record included a physician’s order dated 11/07/23 and indicated a “Target Wt (weight) 65.0 kg (kilograms).” -Pt #4’s intradialytic treatment records, dated 10/31/23 - 11/07/23, were reviewed and indicated that the prescribed target weight of 66.5 kg was not met. The clinical record lacked documentation that staff notified the licensed nurse or the physician of the target weight not met for the following dates: -10/31/23 Post dialysis weight 69.9 kg (over target weight by 4.9 kg). -11/02/23 Post dialysis weight 67.9 kg (over target weight by 2.9 kg). -11/04/23 Post dialysis weight 66.8 kg (over target weight by 1.8 kg). -11/07/23 Post dialysis weight 67.3 kg (over target weight by 2.3 kg). 3. Pt. #5’s clinical record was reviewed. Pt.#5 was admitted to the Facility on 8/22/23 with a diagnosis of ESRD. The Pt. #5’s clinical record included a physician’s order dated 10/17/23 for a “Target Wt 135.5 kg.” -Pt.#5’s intradialytic treatment records dated 10/31/23 - 11/11/23, were reviewed and indicated that the prescribed target weight of 135.5 kg was not met. The clinical record lacked documentation that staff notified the licensed nurse or the physician of the target weight not met for the following dates: -10/31/23 Post dialysis weight 139.5 kg (over target weight by 4.0 kg). -11/02/23 Post dialysis weight 138 kg (over target weight by 2.5 kg). -11/04/23 Post dialysis weight 136 kg (over target weight by 1.0 kg). -11/07/23 Post dialysis weight 138 kg (over target weight by 2.5 kg). -11/09/23 Post dialysis weight 139.4 kg (over target weight by 3.9 kg). -11/11/23 Post dialysis weight 139 kg (over target weight by 3.5 kg). 4. Pt. #6’s clinical record was reviewed. Pt.#6 was admitted to the Facility on 9/18/17, with a diagnosis of ESRD. The clinical record included physician’s order for a target weight on 10/27/23 of 120 kg and on 11/07/23, a target weight of 124 kg. -Pt.#6’s intradialytic treatment records dated 11/01/23 - 11/13/23, were reviewed and indicated the prescribed target weight was not met. The clinical record lacked documentation that staff notified the licensed nurse or the physician of the target weight not met for the following dates: 11/01/23 Post dialysis weight 125.8 kg (over target weight by 5.8 kg). 11/03/23 Post dialysis weight 125.7 kg (over target weight by 5.7 kg). 11/06/23 Post dialysis weight 126.3 kg (over target weight by 6.3 kg). 11/08/23 Post dialysis weight 125.4 kg (over target weight by 1.4 kg). 11/13/23 Post dialysis weight 125.5 kg (over target weight by 1.5 kg). 5. Pt. #7’s clinical record was reviewed. Pt.#7 was admitted to the Facility on 02/08/21 with a diagnosis of ESRD. The clinical record included a physician’s order dated 10/27/23, of “Target Wt 50.0 kg.” -Pt.#7’s intradialytic treatment records dated 11/02/23 - 11/11/23, were reviewed and indicated that the prescribed target weight of 50.0 kg from 11/02/23 to 11/11/23 was not met. The clinical record lacked documentation that staff notified the licensed nurse, or the physician of the target weight not met for the following dates: -11/07/23 Post dialysis weight 54.1 kg (over target weight by 3.6 kg). -11/09/23 Post dialysis weight 53.5 kg (over target weight by 3.0 kg). -11/11/23 Post dialysis weight 53.6 kg (over target weight by 3.1 kg). 6. On 11/16/23 at approximately 11:15 AM, an interview was conducted with a Registered Nurse (RN/E#4). E#4 stated that when the prescribed target weight is not met, the PCT (patient care technician) should notify the RN. The RN should also look at this information when completing the post treatment assessment and notify the physician that the target weight was not met by 0.5 kg over or under. E#4 confirmed that for the above patient’s there was no documentation that the target weight not met was addressed.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 34411 Based on document review and interview, it was determined that for 1 of 1 (Pt #1) clinical reviewed for behavioral management, the Medical Director failed to ensure that the staff adhered to patient care policies, by not following a progressive behavioral management process advised by the Renal Network, prior to not allowing a patient a dialysis treatment. Findings include: 1. The Facility’s policy titled, “Patient’s Standard of Conduct, Responsibilities and Facility Rules”(dated 10/2021), was reviewed, and required, “Potential consequences for failing to comply. I understand I must comply with all stated Patient’s Standards of Conduct, Responsibilities and Facility Rules...Should I continue to behave in a way that is detrimental to the proper functioning of the facility, the interdisciplinary team, with the guidance of the ESRD Network, will follow a progressive behavioral management process up to and including involuntary discharge...” 2. The clinical record of Pt. #1 was reviewed on 11/14/2023. Pt. #1 was admitted on 10/8/2021, with a diagnosis of end-stage renal disease (ESRD). Pt #1 is on the current census and has scheduled HD (hemodialysis) treatments 3 days a week, Tuesday, Thursday, Saturday, for 4 hours. -Pt #1’s nursing notes from 11/7/2023-11/14/2023, were reviewed. The notes included the following on: -11/11/2023: “Patient was notified by Registered Nurse [RN/E #4] and [MD #1] about patient’s refusal to draw labs. Patient was informed that in order to continue receiving treatment at this facility patient needs to have labs drawn. Patient still refused and stated to RN by quote ‘I won’t have my labs drawn until December 13th, nor will I be coerced or intimidated into doing labs’ ...Discussed with patient about labs being crucial for MD to prescribe appropriate dialysis treatment regimen as well as reiterated to the patient that if her nephrologist will not provide any treatment order staff cannot provide treatment ...” -11/13/2023: “ ...Myself [E #1] and [E #3] followed up and talked with the Renal Network 10 ...Their medical review board agreed the patient needs to agree to have [Pt #1] labs drawn as part of safe dialysis treatment and that it places the patient and our staff at risk ...Renal Network recommended to provide the patient with a 30-day involuntary discharge notice rather than proceeding with an immediate discharge. MD and medical director made aware ...” -11/14/2023: “[E #4/RN] attempted to speak to patient in morning about needing lab draws for treatment. Patient refused to acknowledge RN and continued to attempt to enter treatment room while ignoring RN.” -11/14/2023: “[MD #1] wrote an order not to dialyze the patient today and thereafter if [Pt #1] won’t agree to have her labs drawn or if [Pt #1] cannot provide any recent labs for [MD #1] to review if its ok to continue treating [Pt #1] in the clinic ...” -Pt #1’s Physician note, dated 11/11/2023, documented by MD #1, included, “Seen today. Tried to talk to patient, [Pt #1] ignored me initially ...I explained to [Pt #1] that a decision was made to immediately discharge [Pt #1] involuntarily based on [Pt #1] behavior for past year ...[MD #1] said to [Pt #1], despite all this ...[MD #1] still giving [Pt #1] one more chance, [MD #1] told [Pt #1] will not be allowed back in the clinic if [Pt #1] continues to refuse ...” -Pt #1’s physician order, by MD #1, dated 11/14/2023, included, “The patient cannot be put on the dialysis machine w/out (without) agreeing for [Pt #1] labs to be drawn today.” Pt #1 was not allowed treatment on 11/14/2023 due to refusal of labs. Pt #1’s 11/14/2023 treatment sheet lacked any treatment data, indicating that the patient did not receive treatment. Pt #1’s clinical record lacked documentation that a 30-day notice was given to Pt #1, as advised by the Renal Network, prior to the Facility not allowing Pt #1 treatment. 3. On 11/14/2023 at 12:25 PM, a phone interview was conducted with the Nephrologist (MD #1/Pt #1’s Attending). MD #1 stated that he is the covering Medical Director at this time. MD #1 stated that labs are needed to treat a dialysis patient. MD #1 stated that Pt #1 had been refusing labs and this has become a liability on himself and the clinic. MD #1 stated that Pt #1 came in on 11/14/2023 and would not let the staff draw labs. MD #1 stated that Pt #1 could not continue treatment without labs. MD #1 stated that the team met to discuss an involuntary discharge for Pt #1. MD #1 stated that Pt #1 had not been given the required 30-day involuntary discharge letter, as of date. 4. On 11/14/2023 at 1:20 PM, an interview was conducted with the Facility Administrator (E #1). E #1 stated that Pt #1 came for treatment today (on 11/14/2023). E #1 stated that [MD #1] said that if Pt #1 got labs drawn today, then Pt #1 could get treatment today. E #1 stated that Pt #1 was not allowed treatment per MD order. E #1 stated that E #1 had been in touch with the Renal Network and that they advised to give the patient a 30-day involuntary notice if the patient continues to not comply with policy. E #1 stated that there was no advice from the Renal Network to not allow treatment, but the staff went according to MD #1’s order. E #1 acknowledged that Pt #1 has not been given a 30-day notice.”