Davita Main Street Dialysis

“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: 39228 Based on observation, staff interview, and review of facility documents, it was determined the facility failed to ensure that one of one Emergency Code Cart is secure and contains all necessary medications and equipment in the event of an emergency. Findings include: On 7/22/24 at 1:21 PM, Staff (S) 10, the Clinical Coordinator, stated that the facility had one Emergency Code Cart located in the Hemodialysis Treatment Area. S10 provided documentation of an itemized checklist of the Emergency Code Cart’s contents, and the document indicated that the cart was last checked in June of 2024. Upon initial review of the Emergency Code Cart, it was discovered that the cart did not contain a lock. Upon discovery, S10 stated that he/she was not sure why the cart was unlocked and explained that it usually is secured with a breakaway lock and that he/she would ensure that it would be locked. Review of the contents of the kit revealed that the following items indicated on the checklist were not present: - Two red lab specimen tubes - The cart also contained the following: - 50 milligram (mg)/ml (milliliters) vials of diphenhydramine (Benadryl): The par level on the checklist stated that 25 vials were needed, and only 23 vials were present. This was two vials less than expected. - 30 ml syringes: The par level on the checklist stated that six syringes were needed, and only four were present. This was two syringes less than expected. - Lavender top lab specimen tubes: The par level on the checklist stated that six lavender tubes were needed and only four were present. This was two less than expected. - N95 respirator masks: The par level on the checklist stated that five N95 masks were needed, and only two N95 masks were present. This was two less than expected. - 19 vials of calcium gluconate 1000 mg/10 ml were present. The label indicated that all vials of calcium gluconate expired two months prior, in May 2024. This medication was not included on the itemized checklist. Upon interview with S10 at 1:40 PM, S10 confirmed that the items were missing from the cart and stated that he/she would replace them. S10 also removed the expired calcium gluconate vials from the cart and replaced them with non expired vials and stated that the medication would be added to the checklist. Review of the facility policy titled, “Emergency Equipment Checks,” last revision date April 2024, stated, “... Policy: ... 3. The following equipment checks will be performed by a licensed nurse to verify the designated equipment is available and functional: ... Breakaway lock is intact ... Emergency cart is clean, operational and supplies/medications have not expired. 4. The Emergency Equipment Checklist may be used for documentation of emergency equipment checks. 5. The emergency checklist will be developed by the facility based on Medical Director input as to the supplies needed on the emergency (crash) cart and will be used to verify that the cart has been checked. ... 9. the part of the cart containing medications and other supplies will be sealed with a break away lock ...” N.J.A.C. 8:43A-15.1(d)”

“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: 39223 Based on one of two observations of initiating hemodialysis through a vascular access, review of facility policy, and staff interview, it was determined that the facility failed to ensure that staff perform hand hygiene before donning (putting on) and after removing gloves. Findings include: On 7/22/24 at 10:18 AM, Staff (S) 9, a Patient Care Technician, entered Station 3, performed hand hygiene, and donned a pair of clean gloves. S9 proceeded to insert two needles into Patient (P) 7’s right arm vascular access. S10, a Registered Nurse, then attached two saline pre-filled syringes, and injected the contents into the vascular access. After securing the needles to P7’s arm, S9 disposed of a used alcohol swab and two end caps that both contained visible blood on the threads. S9 removed his/her gloves and, without the benefit of performing hand hygiene first, donned a new pair of clean gloves. S9 then removed two syringes from P7’s two vascular access bloodlines and connected the patient bloodlines to the hemodialysis treatment machine. S9 disposed of the two blood filled syringes and doffed (removed) his/her gloves. Without the benefit of performing hand hygiene first, S9 then donned a new pair of clean gloves and made contact with the patient. During an interview at 10:32 AM, S9 stated that the facility policy is to wash his/her hands between glove changes. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “... HAND HYGIENE 1. All teammates, Physicians and Non-Physicians (NPP) will perform hand hygiene ... b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and delivery system contact ...” N.J.A.C. 8:43A-24.8(b)”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 39223 Based on observations, staff interview, and review of facility documents, it was determined that the facility failed to ensure that: 1) staff clearly separate clean supplies from dirty supplies to prevent potential cross contamination in one of one observation of initiation of hemodialysis through a Central Venous Catheter; 2) medications are prepared aseptically in designated clean areas in one of one observation of medication preparation; and 3) five of five alcohol based hand sanitizers that are available for use on the treatment floor, are not expired. Findings include: 1. On 7/22/24 at 11:37 AM in Station 5, Staff (S) 11, a Registered Nurse, removed a blood-filled syringe from Patient (P) 8’s blue catheter limb, placed the blood-filled syringe on the chairside table, next to a pile of clean gloves, and connected a luer-loc adapter. S11 then proceeded to fill two Vacutainer tubes with blood before disconnecting the luer loc adapter and placing it on top of the pile of clean gloves. S11 connected a saline pre-filled syringe to the blue catheter limb and injected the contents. Next, S11 connected the patient bloodlines to the hemodialysis machine. S11 removed and disposed of the use alcohol pads, two blood-filled syringes, and the used luer-loc adapter. S11 did not remove the pile of gloves from the chairside table. S11 exited the station, removed his/her gloves and performed hand hygiene. The pile of gloves were left on the chairside table, available for staff use. During an interview at 12:10 PM, S11 stated that he/she tries to keep all clean supplies separated from dirty supplies. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “... SUPPLIES 8. Supplies will be stored in a manner that maintains their integrity. ... d. Anytime the integrity of a package with or without an expiration date is in question, i.e., torn, ripped, wet or contaminated, the package and its contents must be disposed of and not used ...” 39228 2. On 7/22/24 at 10:50 AM, S11, a Registered Nurse, entered the hemodialysis treatment floor and walked to the medication preparation area, located across from Station 3. S11 was wearing the following personal protective equipment (PPE): a blue gown, a face shield and a face mask positioned under his/her chin. S11 then prepared two syringes of Heparin Sodium at a countertop. S11 then entered Station 5 while wearing the same PPE. During an interview on 7/23/24 at 2:38 PM, S10, the Clinical Coordinator, stated that the countertop area located from across from Station 3 is a designated clean medication preparation area on the treatment floor. S10 stated that if the staff wear a gown, it should be a clean gown that is dedicated to the medication preparation area. S10 also stated that staff should not wear a face shield and mask unless they are clean and dedicated to the medication preparation area. S10 confirmed that the PPE that S11 was wearing when preparing the medications on 7/22/24 was not dedicated medication preparation area PPE. S10 explained that staff wore blue gowns while in the hemodialysis treatment area. S10 explained that when staff prepared medications, they should switch to a PPE gown other than the designated blue PPE gowns. S10 explained that he/she will educate the staff on wearing PPE dedicated to the medication preparation area. Facility policy titled, “Infection Control For Dialysis Facilities,” revised April 2023, stated, “PPE ... PPE is to be: a. Removed prior to leaving the treatment area. ...c. PPE is not to be worn in non-treatment areas ... Facility Hygiene 16. Clean areas should be clearly designated for the preparation, handling, and storage of medications...” 3. On 7/22/24 at 11:30 AM, five expired bottles of “Purell” alcohol-based hand sanitizer were found on the treatment floor as follows: - One bottle, located at the dirty sink across from Station 1, expired 5/2024. - Three bottles, located at the nurses station area across from Station 4, expired 5/2024. - One bottle, located on the chaise wall in Station 9, expired 5/2024. The above findings were confirmed by S1, the Facility Administrator, upon discovery. Facility policy titled, “Infection Control For Dialysis Facilities,” revised April 2023, stated, “... Hand Hygiene ... Use of an alcohol-based hand rub may be substituted for handwashing. ...” N.J.A.C. 8:43A-24.8(b)”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 39228 Based on document review and staff interview, it was determined that the facility failed to ensure that microbiological samples are collected in the “worst case” scenario before sanitation and disinfection of the water treatment system in three of six months of microbial monitoring reviewed. Findings include: Reference: Association for the Advancement of Medical Instrumentation (AAMI) RD52: 2004, Hemodialysis systems stated, “... 7.2 Microbial monitoring methods 7.2.1 General ... Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. ...” A review of RO (Reverse Osmosis) Unit Chemical Disinfection logs and the Culture and Endotoxin lab results for February 2024 through July 2024 revealed the following: In February 2024, the RO was disinfected with Minncare on 2/3/24. Two days later, on 2/5/24, water samples to test for bacteria and endotoxins were drawn from the RO treatment system. The RO treatment system was disinfected with Minncare on 3/30/24. Three days later, on 4/2/24, water samples to test for bacteria and endotoxins were drawn from the RO treatment system. The RO treatment system was disinfected with Minncare on 5/4/24. Three days later, on 5/7/24, water samples to test for bacteria and endotoxins were drawn from the RO treatment system. During an interview on 7/23/24 at 12:55 PM, Staff (S) 12, the Biomedical Technician, stated “I try and get them on Mondays or Tuesdays or whenever I can.” Facility policy titled, “Water Culture Policy,” last revision date April 2024, stated, “... Policy: ... 4. Routine water cultures are collected monthly and within 72 hours prior to scheduled disinfection of distribution systems. ...” N.J.A.C. 8:43A-24.10(a)(2)”

“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 facility documents, it was determined the facility medical director failed to ensure that: 1) the medical record contains a completed Early Termination of Treatment Against Medical Advice form and documentation by the Registered Nurse (RN) that the patient’s attending nephrologist was notified of the early termination of hemodialysis treatments in three of ten treatments reviewed for Patient (P) 1, and in five of ten treatments reviewed for P5; and 2) medications are stored in accordance with facility policy and procedure in two of two observations of medication storage areas in the facility. Findings include: 1. A review of P1’s medical record revealed the following: The “Patient Summary Report” stated, “... Active Treatment Order(s) In-Center Hemodialysis Treatment ... Frequency/TX [treatment] time Three times a week, 4hr [hour] 0min [minute] ... Start Date 07/10/2024 ...” On 7/17/24, the “Treatment Details Report” indicated that P1’s initiation of hemodialysis began at 6:19 AM and that treatment was terminated at 9:47 AM, 32 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence of a completed Early Termination of Treatment Against Medical Advice form and that P1’s attending nephrologist was notified that the prescribed treatment time was not met. On 7/19/24, the “Treatment Details Report” indicated that P1’s initiation of hemodialysis began at 6:42 AM and that treatment was terminated at 9:43 AM, 59 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence of a completed Early Termination of Treatment Against Medical Advice form and that P1’s attending nephrologist was notified that the prescribed treatment time was not met. On 7/22/24, the “Treatment Details Report” indicated that P1’s initiation of hemodialysis began at 6:29 AM and that treatment was terminated at 9:23 AM, one hour and six minutes earlier than the prescribed treatment time. The medical record lacked documented evidence of a completed Early Termination of Treatment Against Medical Advice form and that the P1’s attending nephrologist was notified that the prescribed treatment time was not met. On 7/23/24 at 1:44 PM, Staff (S) 10, the Clinical Coordinator, stated “the patient comes from a rehab [rehabilitation center] and transportation has been an issue, however the nurse should have written a note indicating that they notified the doctor and they should still be filling out an AMA (Against Medical Advice) form.” S10 confirmed that there was no physician notification documented by the RN and that there were no signed Early Termination of Treatment Against Medical Advice forms on 7/17/24, 7/19/24 and 7/22/24. A review of P5’s medical record revealed the following: The “Patient Summary Report” stated, “... Active Treatment Order(s) In-Center Hemodialysis Treatment ... Frequency/TX time Three times a week, 4hr 0min ... Start Date 06/05/2024 ...” On 7/3/24, the “Treatment Details Report” indicated that P5’s initiation of hemodialysis began at 3:39 PM and that treatment was terminated at 6:28 PM, one hour and 11 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence of a completed Early Termination of Treatment Against Medical Advice form and that P5’s attending nephrologist was notified that the prescribed treatment time was not met. On 7/5/24, the “Treatment Details Report” indicated that P5’s initiation of hemodialysis began at 3:37 PM and that treatment was terminated at 7:02 PM, 35 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence of a completed Early Termination of Treatment Against Medical Advice form and that P5’s attending nephrologist was notified that the prescribed treatment time was not met. The “Patient Summary Report” stated, “... Active Treatment Order(s) In-Center Hemodialysis Treatment ... Frequency/TX time Three times a week, 4hr 15min ... Start Date 07/06/2024 ...” On 7/10/24, the “Treatment Details Report” indicated that P5’s initiation of hemodialysis began at 3:56 PM and that treatment was terminated at 6:42 PM, 1 hour and 29 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence of a completed Early Termination of Treatment Against Medical Advice form and that the P5’s attending nephrologist was notified that the prescribed treatment time was not met. On 7/17/24, the “Treatment Details Report” indicated that P5’s initiation of hemodialysis began at 3:17 PM and that treatment was terminated at 6:58 PM, one hour and 34 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence of a completed Early Termination of Treatment Against Medical Advice form and that the P5’s attending nephrologist was notified that the prescribed treatment time was not met. On 7/19/24, the “Treatment Details Report” indicated that P5’s initiation of hemodialysis began at 6:29 AM and that treatment was terminated at 9:23 AM, one hour and 21 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence of a completed Early Termination of Treatment Against Medical Advice form and that the P5’s attending nephrologist was notified that the prescribed treatment time was not met. On 7/23/24 at 1:50 PM, S10 stated “the patient is not compliant with her treatments and shortens her treatments frequently but the nurses should be documenting that they notified the doctor and completing the AMA form.” On 7/24/24 at 9:45 AM, S1, the Facility Administrator confirmed that there were no completed Early Termination of Treatment Against Medical Advice forms on 7/3/24, 7/5/24, 7/10/24, 7/17/24 and 7/19/24. Review of facility policy and procedure titled, “Prescribed Treatment Time Not Met,” Revision date: April 2024, stated, “... Policy: A. Completion Of The Early Termination of Treatment Against Medical Advice Form 1. The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time. ... 4. A RN must countersign all ... forms. ... B. Prescribed Treatment Time Not Met 1. If shortened/early termination of treatment time exceeds 30 or more minutes, the will notify the patient’s attending nephrologist ... 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: ... Whether the patient’s nephrologist was notified, A description of the follow-up medical orders provided by the patient’s attending nephrologist (if any), ...” N.J.A.C. 8:43A-24.4(a) 2. On 7/22/24 at 2:10 PM, review of the medication storage cabinet located on the treatment floor revealed the following: One box of Vancomycin Hydrochloride that contained 19 vials, expiration date July 1, 2024, was found on the top shelf of the medication storage cabinet. Two boxes of Vancomycin Hydrochloride that contained 10 vials in each box, expiration date July 1, 2024, was found on the bottom shelf of the medication storage cabinet. The above findings were confirmed by S10, Clinical Coordinator, upon discovery. S10 then discarded the medications. Facility document titled, “Renal Dialysis Center Pharmacy Consultation for [facility name] ... Survey performed on 05/08/2024” stated, “... General Concern & Recommendation, Observation ... Vancomycin 1gr [gram] will expire 7/1/24 ... Recommend removal from stock on or before the expiration dates. ...” At 2:30 PM, review of the medication refrigerator, located in the Clean Utility Room, revealed the following: One box of Influenza Vaccine Fluzone High Dose that contained seven pre-filled syringes, expiration date 6/2024, was found. One box of Influenza Vaccine Flucelvax Quadrivalent that contained seven pre-filled syringes, expiration date 6/23/24, was found. One Hepatitis B Vaccine Recombinant Energix B vial that had approximately one quarter ml (milliliter) of solution in the vial, had the cap off and contained a visible needle puncture hole, was available for use. The above findings were confirmed with S10 upon discovery. S10 discarded the expired medications and stated “We usually check the refrigerator monthly and I assign it to staff members but obviously we are not checking it enough.” S10 then stated the Hepatitis B Vaccine Recombinant Energix B vial is a single dose vial and that he/she was unaware of who used the vial and placed it back in the refrigerator. S10 could not confirm when the last time a patient received the vaccine. Facility policy, titled “Medication Policy,” last revision date October 2023, stated, “... Policy: ... 26. Single use vials/ampules must be used for only one (1) patient, ... and if entered, may not be stored for future use. ... 30. ... All medications are checked monthly for expiration dates. ...” N.J.A.C. 8:43A-9.3(a)”