Fmc Winslow

“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: 49828 Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure all emergency equipment is immediately available for use at all times. Findings include: On 4/17/24 at 10:20 AM, a review of the locked emergency evacuation box on “B-side” was conducted and compared to the “Emergency Supply Box List and Expiration Date Checklist” and “Emergency Box Log Incenter- Monthly” documents. The following items on the above reviewed documents were not present in the “B-Side” evacuation box: One blood pressure (BP) kit was expected; No BP kit was present. An undetermined number of tourniquets were expected; No tourniquets were present. At 10:43 AM, a review of the locked emergency evacuation box on “A-Side” was conducted and compared to the “Emergency Supply Box List” and “Expiration Date Checklist, and Emergency Box Log Incenter- Monthly” documents. The following items on the above reviewed documents were not present in the “A-Side” evacuation box: Nine intravenous (IV) administration sets were expected; Eight IV administration sets were present. The following items on the above reviewed documents were expired in the “A-Side” evacuation box: One 17-gauge fistula needle was expected. One expired needle was present. This left the box without a useable 17-gauge needle in the evacuation box in the case of an emergency. At 11:36 AM, the contents of the locked emergency code cart located on the “A-Side” of the facility were reviewed and compared to the facilities, “Crash Cart Checklist” and the “Emergency Code Cart and Medication Checklist (Monthly)” documents. One of the five ampoules of Adrenalin (epinephrine) was expired as of 3/24/24. During an interview at 11:40 AM, Staff (S)8, the Charge Nurse, stated that only four vials are needed in the code cart. S8 stated that the educator had taken medications out of the box, and returned the expired Adrenalin without their knowledge “last Thursday.” The expired medication was easily accessible for use within the cart with the remaining four unexpired Adrenalin vials. During an interview at 2:50 PM, S13, Director of Operations, stated that the “Crash Cart Checklist,” “Emergency Code Cart” and “Medication Checklist (Monthly)” documents should reflect the same items needed in the cart. The undated facility document titled, “Crash Cart Checklist” revealed, “... epinephrine 1:1000 (1mg[milligram]/1ml[milliliter]), Quantity 5 (five) amps [ampoules] ...”. The undated facility document titled, “Emergency Code Cart and Medication Checklist (Monthly)” revealed, “... Verify there is a minimum of 4 (four) epinephrine, 1:1,000 (Adrenalin) at the Medication Station ...” Facility policy titled, “Emergency Medications, Equipment and Supplies,” published 5/1/23 stated, “... Emergency cart: ... An itemized log must be kept indicating the contents and expiration dates of contents. Items approaching expiration must be reordered and replaced prior to the actual expiration date ... Emergency Evacuation Box: ... An itemized log must be kept indicating the contents and expiration dates of contents. Items approaching expiration must be reordered and replaced prior to the actual expiration date ...” 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: 37656 Based on one of two observations of initiation of dialysis through an arteriovenous fistula (AVF), staff interview and facility policy review, it was determined that the facility failed to ensure that staff perform hand hygiene in accordance with facility policy. Findings include: On 4/17/24 at 10:00 AM, Staff (S) 3, a Patient Care Technician, was observed during initiation of dialysis through an AVF. S3, with gloves on, touched the patient’s AVF access site, reached for a stethoscope that was hanging on the pole, and listened for bruit of the access site. After hanging the stethoscope on the intravenous (IV) pole, S3 with the same gloves on, and without performing hand hygiene first, cleaned the arterial and venous sites with an alcohol swab. S3, without removing gloves and performing hand hygiene first, cannulated (the act of inserting a needle into the body to draw off fluid or to introduce medication) both sites of the AVF access. S3 connected the bloodlines from the the patient to the machine and started dialysis treatment. S3 removed his/her gloves and perform hand hygiene after the entire procedure was done. Upon interview at 10:10 AM, S3 stated that as long as he/she doesn’t touch the machine with the gloved hand during the procedure, he/she did not need to change gloves and perform hand hygiene. A review of S3’s Skills Validation Checklist on 4/19/24 indicated that he/she was educated on Access evaluation and preparation of Access (AVF, AVG (arteriovenous graft) on 11/1/23. A review of the facility policy titled, “Access Assessment and Cannulation,” published 7/5/22, stated, “... Assessment of Vascular Access ... Step 6 ... LISTEN: ... Bruit high pitch/whistle ... Clean Stethoscope after assessing a patient. ... Step 9 Remove gloves and perform hand hygiene. ... Needle Placement Procedure ... Step 1 Perform hand hygiene and don (put on) clean gloves ...” A review of the facility policy titled, “Hand Hygiene,” published 11/6/23, stated, “... Hands will be ... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water ... When ... Before performing any invasive procedure such as vascular access cannulation or administration of medications ... immediately after removing gloves ... after contact with inanimate objects near the patient ... After contact with other objects within the patient station or treatment space. ...” N.J.A.C. 8:43A-24.4(b)”

“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: 33556 Based on observation and staff interview, it was determined the facility failed to ensure that a defect free environment is maintained at all times. Findings include: During a tour conducted on 4/17/24, starting at 10:30 AM, and in the presence of Staff (S)12, the Area Technical Operations Manager (ATOM), the following fixtures and/or environmental surfaces were identified as in need of repair. The fibre-reinforced plastic (FRP) wall panels installed near Side B, Station 13 and Station 16 were surfaced damaged, dented, and disconnected from the wall creating an uncleanable gap. The Side A dirty sink cabinet, adjacent to Station 7 was surfaced damaged, delaminated, and creating a floor surface defect under the cabinet. The Side B workstation stainless steel clean and dirty sinks were corroded with a rust-like material. The Side A and Side B workstation cabinetry surface was delaminated with storage drawers binding and not operating smoothly. S12 confirmed the above findings upon discovery and stated they would be repaired as soon as possible. N.J.A.C. 8:43A-17.4(a)13”

“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: 33556 Based on observation and staff interview, it was determined the facility failed to ensure that a means to flush the eyes and/or body are available within the immediate work area in the event that it is needed. Findings include: Reference: OSHA [The Occupational Safety and Health Administration] 29 CFR [Code of Federal Regulations] 1910.151(c) states: “Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick, drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use.” During a tour conducted on 4/17/24 starting at 10:30 AM, in the presence of Staff (S)12, the Area Technical Operations Manager (ATOM), it was determined the currently installed eyewash/shower did not meet the requirement of being within the immediate work area of the acid mixing section of the Water Treatment Room. S12 confirmed the above finding and stated the location of the eyewash/shower would be changed if necessary.”

“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: 37656 Based on observation and staff interview, it was determined the facility failed to ensure that: 1) the tubing for the citru clean disinfecting solution containers are maintained in nine of nine citru clean containers; and 2) the Embrace Pro test strips (strips use in blood glucose meters for testing blood sugar) are maintained in accordance with manufacturer’s instructions. Findings include: 1. On 4/17/24 at 9:50 AM, during tour of the Treatment Room, there were nine plastic bottles in the clean sink across from Station 11, labeled ‘citru clean’ and nine lids with opaque plastic tubing that contained a large amount of blackish discoloration throughout the inner tubing. The citru clean containers are filled with citric acid mix at the end of dialysis treatments to disinfect the internal pathways of the dialysis machines and connects through the tubing’s with blackish substances. Upon interview at 10:00 AM, Staff (S)2, Biomedical Technician, stated that the blackish discoloration maybe due to the friction in connecting to the machine line. S2 stated that he/she will replace the tubing’s. A review of facility policy titled, “General Cleanliness and Infection Control Guidelines,” published, 2/7/22, stated, “... Detergents Germicides and Cleaning Supplies ... All non-disposable containers, ... that are to be reused and have a reasonable likelihood of becoming contaminated, must be inspected, and disinfected on a regularly scheduled basis. Such containers, etc. shall be cleaned and disinfected immediately, or as soon as feasible upon visible contamination. ...” 2. On 4/18/24 at 10:20 AM, during tour of the Treatment Room, an open container of “Embrace Pro” test strips, located in the drawer of the counter across from Station 5, did not contain the date of opening. It was unable to be determined when the bottle was opened. Upon interview on 4/18/24 at 10:30 AM, S5, Registered Nurse, stated that he/she placed an unopened box in the drawer that morning, and did not know who opened it. S5 stated it should be dated with the date of opening. A review of the manufacturer’s instructions of Embrace Pro Test Strips, stated, “... Storage and Handling ... Use all the strips within 4 months after the first opening ...” N.J.A.C. 8:43A-24.11(c)”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 48966 Based on review of one of four in-center hemodialysis medical records reviewed (Patient (P) 6), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that post hemodialysis treatment assessments are completed. Findings include: On 4/18/24, a review P6’s hemodialysis treatment flowsheets revealed the following: On 3/22/24 at 7:00 PM, a pre-treatment “Nursing Evaluation” indicated lungs- decreased breath sounds. The post-treatment “Nursing Evaluation” at 10:49 PM lacked documented evidence of a re-assessment of the patient’s lungs sounds. On 3/25/24 at 6:53 PM, a pre-treatment “Nursing Evaluation” indicated lungs- decreased breath sounds. The post-treatment “Nursing Evaluation” at 10:50 PM lacked documented evidence of a re-assessment of the patient’s lungs sounds. On 3/27/24 at 6:30 PM, a pre-treatment “Nursing Evaluation” indicated lungs- decreased breath sounds. The post-treatment “Nursing Evaluation” at 10:32 PM lacked documented evidence of a re-assessment of the patient’s lung sounds. On 3/29/24 at 6:39 PM, a pre-treatment “Nursing Evaluation” indicated lungs- decreased breath sounds. The post-treatment “Nursing Evaluation” at 10:50 PM lacked documented evidence of a re-assessment of the patient’s lung sounds. On 4/5/24 at 7:02 PM, a pre-treatment “Nursing Evaluation” indicated lungs- decreased breath sounds. The post-treatment “Nursing Evaluation” at 10:59 PM lacked documented evidence of a re-assessment of the patient’s lung sounds. On 4/10/24 at 6:51 PM, a pre-treatment “Nursing Evaluation” indicated lungs- decreased breath sounds. The post-treatment “Nursing Evaluation” at 11:13 PM lacked documented evidence of a re-assessment of the patient’s lung sounds. During an interview on 4/18/24 at 11:54 AM, Staff (S)1, the Clinical Manager, stated if pre-treatment lung sounds are documented by the RN as abnormal, then lungs sounds need to be reassessed post treatment. If the abnormal findings are a chronic condition, then it should be documented as such by the RN. During an interview on 4/18/24 at 1:38 PM, S8, the Charge Nurse, stated that if a patient has new onset abnormal breath sounds, then a post-treatment assessment needs to be documented by the RN. A review of facility policy and procedure titled, “Patient Assessment and Monitoring”, published 5/1/23, stated, “... Post-Treatment Follow the steps below for obtaining post-treatment assessment data: ... 1 ... Lungs sounds ... The registered nurse will assess/reassess post treatment as indicated. ... 2 Document findings in the patient’s record. ...” N.J.A.C 8:43A-8.4(b)”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 49828 Based on medical record review, staff interviews, and review of facility documents, it was determined that the facility failed to ensure changes in mental status documented on the Plan of Care (POC) are reported to the physician for one of one patient with a change in mental status. Findings include: A review of the medical record of Patient (P)4 indicated a physician order to receive Hemodialysis treatments for four hours, three times per week. Further review of the medical record revealed the following: P4’s annual POC was completed on 6/23/23. The section titled, “Change in Mental Status” stated the following: “... received alert and oriented x 3 [refers to the patient being alert and oriented to person, place and time]... Identify cause and provide treatment: no complaints ... Address symptoms: no changes at the moment ...” The hemodialysis “Treatment Sheet” dated 3/16/24 contained a Nursing Evaluation for Pre-Treatment which stated P4’s mentation was “... Alert, Oriented ... Speech Clear ...” The next documented hemodialysis “Treatment Sheet” dated 3/21/24, indicated that P4 arrived at 5:43 AM. Post-Dialysis Vitals and Evaluation revealed P4 received dialysis for 3 hours and 39 minutes before ending their dialysis treatment at 9:32 AM. This was 21 minutes less than the ordered hemodialysis treatment time. The Treatment Sheet dated 3/21/24 indicated a change in mentation from the last hemodialysis Treatment Sheet provided dated 3/16/24: “Nursing Evaluation: Evaluation: 3/21/24 05:54 AM, Notes: pain 0/10-awake but slow to respond, cannot ascertain orientation as pt [patient] cannot complete full sentence, [sign indicating positive] nausea, spitting up..Zofran [nausea medication] given, wheelchair to seat, feels weak ...” There was no documented evidence that the physician was made aware of P4’s abnormal presentation before hemodialysis treatment was initiated. “Nursing Evaluation: Evaluation: 03/21/24 11:28 AM, Notes: Sent to emergency room post treatment for worsening mental status..patient not able to respond to simple commands, [sign indicating positive] blank stare..patients’ fiancé came to see patient and agreed they needed emergency room ... md [medical doctor][initials] aware ... hemostasis 20-25 mins [minutes] ... patient taken via 911.” During an interview on 4/18/24 at 2:22 PM, Staff (S)1, the Clinic Manager, and S8, the Charge Nurse, stated that there was no indication that the physician, or the charge nurse were notified of the abnormal pretreatment nursing evaluation and should have been. Facility policy titled, “Patient Assessment and Monitoring,” published 5/1/23, stated, “... The RN (Registered Nurse) will notify the patient’s physician/physician extender of any abnormal findings, if necessary, based on clinical judgement for additional instruction ...” Facility policy titled, “Nursing Supervision and Delegation,” published 11/6/23, stated, “... Registered nurses who are not the nurse in charge must report abnormal findings and interventions to the nurse in charge ...” N.J.A.C 8:43A-24.6(d)(4)”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 39223 Based on staff interviews and review of facility documents, it was determined that the facility failed to trend the causes of patient deaths. Findings include: On 4/19/24 at 10:54 AM, a review of the facility’s Quality Improvement Performance Improvement (QAPI) for mortality was completed with Staff (S)13, Director of Operations, S1, Clinic Manager, and S8, Charge Nurse. The following was revealed: The QAPI meeting, dated 10/27/23, identified two patient deaths had occurred and contained individual patient death analysis. There was no documented evidence that a review of the causes for patient deaths were compared to the previous causes for patient deaths in order to identify possible trends in the causes for patient deaths. The QAPI meeting dated 11/27/23, identified one patient death that occurred and contained individual patient death analysis. There was no documented evidence that a review of the causes for patient’s death were compared to the previous causes for patient deaths in order to identify possible trends in the causes for patient deaths. The QAPI meeting dated 12/29/23, identified one patient death that occurred and contained the individual patient death analysis. There was no documented evidence that a review of the causes for patient’s death were compared to the previous causes for patient deaths in order to identify possible trends in the causes for patient deaths. The QAPI meeting dated 1/26/24, stated that there were no patient deaths. The QAPI meeting dated 2/26/24, identified two patient deaths that occurred and contained the individual patient death analysis. There was no documented evidence that a review of the causes for patient’s death were compared to the previous causes for patient deaths in order to identify possible trends in the causes for patient deaths. The QAPI meeting dated 3/19/24, identified one patient death that occurred and contained the individual patient death analysis. There was no documented evidence that a review of the causes for patient’s death were compared to the previous causes for patient deaths in order to identify possible trends in the causes for patient deaths.. During an interview at 10:54 AM, S13 stated that only individual analysis was conducted during the mortality reviews. During an interview at 12:10 PM, S14, the Medical Director, stated that at QAPI will review individuals who expired during the previous month, but do not review the previously analyzed patient deaths to compare. A review of facility policy titled, “Quality Assesment and Performance Improvement,” published 5/2/22, stated, “... An effective and successful review of the QAPI meeting and program activities will include: ... Performing a Root Cause Analysis on the identified opportunities to include: Identification of commonalities, circumstances, conditions or barriers that are impacting quality improvement and facility indicators. Following a Root Cause Analysis, action plans will be determined and prioritized by the QAPI Committee, considering the prevalence and severity of identified problems and by ranking those which have the potential to affect patient health and safety as a higher priority than those that do not have such potential. ...” N.J.A.C. 8:43A-24.18(c)”

“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: 39223 Based on observation, medical record review, staff interview, and review of facility documents, it was determined that the Medical Director failed to: 1) implement facility policy to ensure that medications are administered as ordered for one of two patients (Patient (P)15); and 2) ensure that staff prepare medications in accordance with facility policy. Findings include: 1. On 4/17/24 at 10:42 AM, Staff (S)9, a Registered Nurse, prepared a dose of 0.5 mcg (micrograms) of Calcitriol for P15. S9 reviewed a printed label that contained P15’s information and medication order for 0.5 mcg Calcitriol. S9 then labeled with medicine cup containing the Calcitriol and walked into Station 6. S9 placed a cup of water and the medication cup on the chairside table and then exited the patient station. S9 disposed of trash and performed hand hygiene. During this time, P15 looked at the medicine and asked S9 what was the medication. S9 answered that it was the patient’s vitamin D. P15 then informed S9 that he/she had already had taken that medication and that S9 had administered this medication to him/her. S9 logged into the electronic medical documentation system and was able to determine that P15 had already been administered 0.5 mcg Calcitriol earlier that morning. A review of P15’s hemodialysis treatment sheet indicated that the patient received the 0.5 mcg Calcitriol at 8:35 AM. S9 removed the medicine and cup of water upon confirming the patient had already taken the medication and disposed of it. During an interview at 11:04 AM, S9 stated that the process for medication administration includes the Charge Nurse printing out labels with the patient’s information and medications for the whole shift. S9 stated that two labels were printed for the same medication order and that is why he/she prepared the second dose. During an interview at 11:50 AM, S8, the Charge Nurse, stated that at the beginning of each shift, he/she will print out a label for all the patient medications to be administered that shift. S8 compares the labels with any new orders and the current patient orders. S8 then gives the labels to the staff nurses to use when they prepare the medications for their assigned patients. S8 stated that S9 requested a reprint of some of his/her patient’s medication labels, and then S8 printed out all the labels for the whole shift a second time. S8 stated that when a nurse is preparing medications for his/her patient, the nurse should check the order either at the medication preparation area, or at the chairside when administering the medication to the patient. Facility policy titled, “Medication Preparation and Administration,” published 2/6/23, stated, “... Principles for Medication Preparation ... Follow the principles below for medication preparation and administration. ... Right Dose ... Right Time ... Preparing and Administering Medications During Hemodialysis Treatment ... Prior to administration of the medication: ... verify there is a physician order ...” 48966 2. During a tour of the hemodialysis treatment floor on 4/17/24 at 9:55 AM, two pre-drawn three milliliter (ml) syringes, which contained clear liquid, were observed in the second drawer of the mobile medication cart on Side B next to the clean sink area for Patient (P)12. The two syringes each had a white label affixed that indicated they contained Heparin Sodium (an anticoagulant) 1,000 units/ml (milliliter). One syringe indicated 2500 units/2.5 ml arterial red port. The second syringe indicated 2500 units/2.5 ml venous blue port. The two syringes were missing the initials and time it was prepared on the label for post treatment administration. It was unable to be determined at what time the medication was prepared. During an interview at 10:00 AM, S9, a Registered Nurse, explained he/she drew it up for the catheter patient that he/she just put on the dialysis machine. S9 confirmed medication cannot been drawn up more than one hour prior to administration. A review of P12’s flowsheet dated 4/17/24 revealed the treatment start time was 9:45 AM and the treatment ended at 1:53 PM. This was not in accordance with the facility policy of one hour maximum for pre-drawing medications. S9’s personnel file was reviewed and indicated that the Annual Clinical Skills Validation for RNs, which includes medication administration, was last completed on 2/5/24. Facility policy titled, “Medication Preparation and Administration,” published 2/6/23, stated, “... Pre-drawing Medications- Medications maybe drawn up 4 hours prior to administration (unless state specific requirements such as New Jersey, and New Mexico where there is a 1[one] hour maximum for pre drawing medications) ...” N.J.A.C. 8:43A-9.3(a)”