Davita East Paterson Dialysis

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 37656 Based on two of two observations of initiation of dialysis through an arteriovenous fistula (AVF), staff interviews and policy review, it was determined that the facility failed to ensure that staff perform hand hygiene in accordance with facility policy. Findings include: On 7/8/24 at 10:43 AM, Staff (S) 3, a Registered Nurse (RN) entered Station #7 with gloves on, and placed two 10 milliliter (ml) syringes pre-filled with 0.9% Normal Saline solution, a vacutainer (a device used in collecting blood samples), and a green top tube on the side table of the dialysis chair. S3 touched the dialysis machine then drew blood without first removing his/her gloves and performing hand hygiene. At 11:00 AM, S3 was observed during the discontinuation of dialysis through a central venous catheter (CVC) in Station #8. S3, after disconnecting the dialysis bloodlines from the arterial and venous ports, disinfected the ports with alcohol swabs and placed the CVC caps on the ports. S3, still with same gloves on, applied a clean dressing on the CVC threads and taped it. S3 then removed his/her gloves and without performing hand hygiene donned a new set of clean gloves. This was not in accordance with the facility policy and procedure. Upon interview at 11:10 AM, S3 stated that he/she was very nervous and confirmed that hand hygiene should have been performed before and after glove use. 48966 On 7/8/24 at 11:59 AM, while on the Treatment Floor, an observation of the initiation of dialysis through an AVF was conducted in Station #12. While setting up the supplies on the side table of the dialysis chair, S5, a PCT, dropped the package of fistula needles on the floor. S5 picked up the package of needles off the floor and disposed of needles in the red sharps container and removed his/her gloves and donned a new pair of gloves without performing hand hygiene. S5 cleaned the AVF and applied the tourniquet to the patient’s left upper arm and cannulated the AVF. S5 removed the tourniquet off the arm of the patient and removed his/her gloves and donned a new pair of gloves without performing hand hygiene. S5 adjusted the top venous needle of the AVF, removed his/her gloves and donned a new pair of gloves without performing hand hygiene. During an interview at 12:15 PM, S5 stated that he/she always sanitizes his/her hands but did not this time since the gloves did not have blood on them. S5 stated that the hand sanitizer is irritating to his/her skin. S5 confirmed he/she should be performing hand hygiene after removing gloves. A review of S5’s Annual Skills Checklist on 8/29/23 indicated that he/she was educated on Infection Control which includes demonstration of appropriate hand hygiene. A review of the policy titled, “Infection Control For Dialysis Facilities,” revised in April 2023, stated, “... Hand Hygiene 1. All teammates, Physicians, and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, ... d. after patient and dialysis delivery system contact, ... g. before touching clean areas such as supplies, supply cart ...” N.J.A.C. 8:43A-24.8(b)”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 39228 Based on staff interview and a review of facility documents, it was determined that the facility failed to ensure that Granuflo Batch Production Records for the Granuflo dry acid that is mixed at the facility, contained documentation of the calcium (Ca++) formulation used, the date that the dry acid boxes were added, and the date the Granuflo batch was transferred to the storage tank, for one of six records reviewed. Findings include: On 7/8/24, Staff (S) 2, the Biomedical Technician, provided the “Granuflo (132 Gallon) Batch Production Record” form, date mixed 5/22/24, for review. The following portion was left blank in Part 1 of the form: Ca++ (the calcium formulation used). The following portions were left blank in Part 2 of the form: line # (number) 9 did not contain documentation of the date that the dry acid boxes were added and line #15 did not contain documentation of the date the Granuflo batch was transferred to the storage tank. On 7/8/24 at 10:30 AM, the above findings were reviewed with S2. At 10:53 AM, the findings were confirmed by S7, the training Facility Administrator. Review of facility policy titled, “Granuflo Concentrate Dissolution Unit,” Revision date: April 2023, stated, “... Policy: ... 6. A Granuflo Batch Production Record is fully completed for each batch of liquid acid concentrate that is produced. ...” N.J.A.C 8:43A-24.10(a)(5)”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 33557 Based on observation and staff interview on 7/9/24, it was determined that the facility failed to ensure the dialysis facility is maintained to ensure the safety of the patients. Findings include: During a tour of the facility at 10:58 AM,in the presence of Staff (S)1, the Clinical Coordinator, the track for the cubicle curtain in Patient Station #16 was loose from the ceiling. During an interview at the time of discovery, S1 confirmed that the curtain was loose from the ceiling and would be fixed.”

“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: 37656 Based on a review of one of seven medical records (Medical Record #1 [MR1]), staff interviews, and a review of documents, it was determined that the facility failed to provide the necessary care and services to manage the patient’s volume status. Findings include: A review of MR 1 revealed that Patient (P)1 was made unstable on April 30, 2024, due to re-hospitalizations. The treatment flow sheet, dated 6/29/24, revealed that P1’s blood pressures (BP’s) were elevated as follows: At 12:33 PM, the patients BP was 193/84. The Patient Care Technician (PCT) documented in the comments section, “... bp is elevated; asymptomatic.” There was no documentation that the RN was made aware of the elevated BP by the PCT. At 1:03 PM, the patients BP was 186/92. The Registered Nurse (RN) documented in the comments section, “Patient states no complaint at this time ... bp is elevated ...” At 2:33 PM, the patients BP was 184/103. The PCT documented in the comments section, “... bp elevated; asymptomatic; RN aware.” The treatment flow sheet did not contain documentation that the physician was made aware of P1’s elevated BP by the RN prior to the patient’s discharge. The treatment flow sheet dated 7/4/24, revealed that P1’s BP’s were elevated as follows: At 12:43 PM, the patients BP was 187/86. The Registered Nurse (RN) documented in the comments section, “... Patient appears to be tolerating treatment well at this time.” At 1:13 PM, the patients BP was 192/89. The RN documented in the comments section, “... Patient appears to be tolerating treatment well at this time.” At 1:43 PM, the patients BP was 193/89. The RN documented in the comments section, “... Patient appears to be tolerating treatment well at this time.” At 2:13 PM, the patients BP was 196/105. The RN documented in the comments section, “... Patient appears to be tolerating treatment well at this time.” At 2:43 PM, the patients BP was 185/102. The RN documented in the comments section, “... Patient appears to be tolerating treatment well at this time.” At 3:13 PM, the patients BP was 200/97. The RN documented in the comments section, “... Patient appears to be tolerating treatment well at this time; Patient awake; alert; and states no complaints at this time; BP elevated ... will continue to monitor.” At 3:43 PM, the patients BP was 193/114. RN documented in the comments section, “... Patient appears to be tolerating treatment well at this time.” At 3:49 PM, the patients BP was 198/109, and the treatment was terminated. The treatment flow sheet did not contain documentation that the physician was made aware by the RN of P1’s high BP prior to the patient’s discharge. The treatment flow sheet dated 7/6/24, revealed that P1’s BP’s were elevated as follows: At 1:16 PM, the patients BP was 182/88. The RN documented in the comments section, “... Patient’s blood pressure is elevated ... will retake BP.” At 2:16 PM, the patients BP was 177/100. The RN documented in the comments section, “... Patient blood pressure is elevated.” At 2:46 PM, the patients BP was 183/94. The RN documented in the comments section, “... no complaints at this time.” At 4:01 PM, the patients BP was 193/92. The RN documented in the comments section, “Treatment terminated.” The treatment flow sheet did not contain documentation that the physician was made aware by the RN of P1’s high BP prior to the patient’s discharge. A review of the policy and procedure titled, “Pre [before]-Intra [during/within]-Post [after] Treatment Data Collection, Monitoring and Nursing Assessment,” revision date: April 2024, states, “... INTRADIALYTIC DATA COLLECTION/ASSESSMENT ... 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/ inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. ... 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in the patient status. ... ABNORMAL FINDINGS ... the following are considered abnormal findings and should be reported to the licensed nurse and documented on the patient’s medical record ... Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time ... Blood Pressure: Pre dialysis: ... Systolic greater than 180 mm/Hg (millimeter/Mercury) or less than 90 mm/Hg ... Diastolic greater than or equal to 100 mm/Hg ...Blood Pressure -Intradialytic...difference of 20 mm/hg increase or decrease from patient’s last intradialytic treatment BP reading... Blood Pressure Post Treatment: ... Sitting BP for patients that cannot stand: ... Sitting BP greater than 140 mm/Hg or less than 90 mm/Hg ... Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg ...” N.J.A.C. 8:43A-24.4(a)”

“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: 39228 Based on staff interview and review of documents, it was determined the Medical Director failed to ensure that the medical record contains documentation of the reasons for the early termination of a hemodialysis treatment in two of six treatments reviewed for Patient (P) 5. Findings include: A review of P5’s medical record revealed the following: The “Orders” section stated, “... In-Center Hemodialysis Treatment ... Frequency Three times a week ... Treatment Time 3 hr [hours] 15 min [minutes] ... Start Date 04/30/2024 ...” On 6/25/24, the “Treatment Details Report” indicated that P5’s initiation of hemodialysis began at 1:20 PM, and that treatment was terminated at 3:33 PM, 29 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence of the reason the prescribed treatment time was not met. The “Patient Summary Report” stated, “... Active Treatment Order(s) In-Center Hemodialysis Treatment ... Frequency Three times a week, 3hr 15min ... Start Date 07/03/2024 ...” On 7/6/24, the “Treatment Details Report” indicated that P5’s initiation of hemodialysis began at 12:57 PM, and that treatment was terminated at 3:54 PM, 18 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence of the reason the prescribed treatment time was not met. On 7/9/24 at 11:54 AM, Staff (S) 1, the Clinical Coordinator, stated that if a patient leaves early from treatment, the nurse should have written a note in the medical record with the reason why the patient was discharged early. S1 confirmed that there was no documentation on 7/6/24 and 7/9/24 by the RN (Registered Nurse) in medical record of the reasons the treatments were terminated earlier than prescribed. Review of the policy and procedure titled, “Prescribed Treatment Time Not Met,” Revision date: April 2024, stated, “... Policy: ... B. Prescribed Treatment Time Not Met ... 3. If a patient’s treatment is shortened/early terminated, the RN will document the event in the patient’s electronic health record. Documentation will include, as appropriate: The amount of time by which the treatment was shortened, A description of why the treatment was shortened, Whether the patient’s nephrologist was notified, A description of the follow-up medical orders provided by the patient’s attending nephrologist (if any), A description of all other interventions planned to address the shortened treatment, including recommendations to the patient ...” N.J.A.C. 8:43A-24.4(a)”