Fmc - Williamson County

“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: 32822 Based on observation, document review, and interview it, was determined the facility failed to maintain emergency medications in accordance with policy. Findings include: 1. On 4/15/2024 at approximately 11:30 AM- 4:00 PM an observational tour of the dialysis treatment area was conducted. The Facility lacked the following required emergency medications per the facilities policy. 2. The policy titled “Emergency Medication, equipment and Supplies” (published 5/1/2023) was reviewed on 4/16/2024 at approximately 3:00 PM. The policy required, “...These medications and recommended quantities must be maintained at the dialysis facility.... - Calcium Chloride 10% 10 ml pre-filled syringe (2 on hand) or vial (2 on hand). - Sodium Bicarbonate 8.4% 50 ml pre-filled syringe (2 on hand) or Sodium Bicarbonate 50 ml vial plus syringe.(2 on hand) - Diphenhydramine 50 mg pre-filled syringe (2 on hand) or Diphenhydramine 50 mg vial plus syringe (2 on hand). - Epinephrine (Adrenalin) 1:1000% (4 on hand) - Solu-medrol 125 mg vial (2) OR SoluCortef 100 mg vial (2 on hand). - Dextrose 50% 50 ml vial (2 on hand) and syringe(2 on hand) or(1) Glucagon kit 1 mg lyophilized powder in single dose vial for reconstitution. - Naloxone 0.4 mg vial. (1 on hand) “ 3. During the tour, an interview was conducted with the Facility Administrator (E #4), E #4 verbally confirmed there were no medications in the crash cart as the medications were out of stock or unavailable.””

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 39025 Based on observation, document review, and staff interview it was determined the End Stage Renal Disease (ESRD) Facility failed to maintain a sanitary environment to minimize the transmission of infectious agents. Findings include: 1. On 04/16/24 at 10:00 AM, an observational tour of the treatment area was conducted. Two dialysis chairs, # (number) 6 and #12 had torn vinyl on the leg rest exposing the foam material inside, preventing proper cleaning and disinfection. 2. A facility policy titled, “Cleaning and Disinfecting the Dialysis Station” dated 09/05/23 included the following. “ ... Purpose: ... provide guidelines to prevent the spread of infectious disease in according with appropriate regulations, and to maintain a clean, safe, ... environment for patients ... Definition: Dialysis Station: Area including the dialysis machine, chair/bed ... utilized during dialysis treatment ...” 3. An interview was conducted with E#4 (Facility Administrator) on 04/17/2024 at approximately 12:35 PM. E#4 verbally confirmed the material on the chairs was torn which prevents proper cleaning/disinfection.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 32822 Based on observation, and staff interview, it was determined the facility failed to ensure outdated medications were not available for patient use. Findings Include: 1. On 4/15/2024 at between 11:00 AM and 4:00 PM, an observational tour of the treatment area and medication preparation area was conducted. The following multi dose medications lacked the required 28 day expiration date, were observed in the Medication Preparation area : a. One Tuberculin Purified Protein Derivative (Mantoux) multidose vial 5/TU/0, 1 ml intradermally, labeled opened 1-6-2023 lacked the required 28 day expiration date. b. Liqua Cel 32 fluid ounces (watermelon flavor) lacked an open date, the container’s manufacture label indicated use within 3 months of opening, approximately 16 ounces remaining in container.. Liqua Cel 32 fluid ounces (apple flavor) lacked a open date, the container’s manufacture label indicated use within 3 months of opening, approximately 20 ounces remaining in container. c. 6 individual boxes Atropine Sulfate Injection 1 mg/10 ml vial multidose vial’s expired 2/1/2024 Doxercalciferol 4 mg per 2 ml multidose vial, approximately 1 ml left in vial, no open date and no expiration date on vial. 2. On 4/16/2024 at approximately 3:00 PM, the policy titled “Medication Preparation and Administration (published 2/6/2023) was reviewed. The policy required, “Expiration dates for all stored medications are to be monitored on a monthly basis. And “Any open multi dose vials must be discarded 28 days after opening or per manufacturer’s expiration date.” 3. On 4/16//2024 at approximately 4:00 PM an interview was conducted with Facility Administrator (E #4). E #4 reviewed the medications and agreed the medications were expired and should not have not been available for patient use.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 49741 Based on observation and document review, it was determined for 1 of 3 (Pt #9) patients observed during the provision of patient care, the End Stage Renal Disease (ESRD) Facility failed to ensure the patient was wearing a face mask during Central Venous Catheter (CVC) exit site care and throughout per Facility policy. Findings include: 1. On 4/16/24 at 11:30 AM, Patient Care Technician (E #5) was observed performing exit site care on Pt #9 at station #10. E #5 failed to provide a mask for Pt #9 prior to and throughout the procedure. 2. On 4/16/24 at 2:00 PM, the “Central Venous Catheter Dressing Change” policy was reviewed. Under “Removal of Dressing and Inspection of Site ... Note: The patient and Inpatient Services Staff must wear a mask for all procedures that require accessing the catheter to help prevent contamination by airborne nasal bacteria ... Supplies: The following supplies are needed for this procedure: Two (2) masks, one (1) for the patient and one (1) for the Inpatient Services Staff ... Step #2. Apply a mask to the patient and the Inpatient Services Staff.” 3. On 4/16/24 at approximately 2:30 PM, an interview with the Facility Administrator (E #4) was conducted. E #4 stated “the staff are not following procedure. The patient should have been wearing a mask.””

“INVENTORY CONTROL CFR(s): 494.50(b)(1) 9.2 Inventory control Reprocessing supplies should be used on a first-in, first-out basis, and outdated supplies should be identified and discarded. This Standard is not met as evidenced by: 32822 Based on observation and staff interview, it was determined the staff failed to ensure all inventory of patient care supplies were discarded when expired. Findings include: 1. A tour of the treatment area and storage areas was completed on 4/15/2024 between 11:00 AM and 4:00 PM. During the tour the following supplies were found outdated and were available for patient use. a. one container of Residual Chlorine Reagent strips with bleach indicator, 100 strips was labeled opened on 2/27/2024. The manufacture expiration date was 12/23. b. thirty six 14 G X 1 inch Disposable A.V. Fistula Needle set expired 3/12/2024 four 15 G X 1 1/4 inch Disposable A.V. Fistula Needle set expired 4/11/2023 twenty-two 17 G X 25 mm fixed wing, with black eye, Disposable A.V. Fistula Needle Sets. expired 3/27/2024 2. On 4/15/2024 at approximately 4:30 PM, an interview was conducted with the Facility Administrator (E #4). E #4 reviewed and agreed the supplies were expired and should have not been available for patient use.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 32822 Based on observation, document review and interview, it was determined for 3 of 14 (Station #8. 9 and 11) patients the Facility failed to ensure that vascular access was visible at all times. Findings include: 1. On 4/17/2024 at approximately 8:45 AM - 9:15 AM a tour of the treatment floor was performed. The following patients had their CVC access site covered: a. Patient in Station #8 had a orange quilt covering the patient’s CVC access site in the left upper chest.. b. Patient in Station #9 had a blue blanket covering the patient’s CVC access site in the left upper leg. c. Patient in station #12 had a blue neck pillow covering the CVC access in the right upper chest. 2. The policy titled “Patient Monitoring and Safety Checks During Hemodialysis Treatment” (published 9/5/2023) was reviewed on 4/17/2024 at approximately 10:00 AM. The policy indicated under “Safety Check-Access”: Confirm each patient’s face and access are uncovered.” 3. On 4/17/2024 at approximately 9:30 AM, a interview was conducted with the Facility Administrator (E #4). E #4 stated, “all patients must have their access site visible at all times.””