Fmc - Niceville

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 45827 Based on record review, policy review and interview, the facility failed to ensure patient care staff maintained current cardiopulmonary resuscitation (CPR) certification for 1 of 3 sampled staff members (Staff Member B). The findings include: A personnel record review for Staff Member B, a Licensed Practical Nurse (LPN), revealed a hire date of 07/05/2022. The record review also revealed an expired American Red Cross Certificate of Completion for Basic Life Support (course for healthcare professionals and other personnel who need to know how to perform CPR). A review of the facility’s Human Resource policy, “Credential and Verification Requirements,” effective date 12/15/20, identified on Page 2, “Credential Renewal, Employee Action Required, 1. Renew required credential(s) prior to the expiration date ..., 2. Immediately notify supervisor if credential is not renewed prior to its expiration date.” On 11/14/2024 at approximately 12:10 PM, an interview was conducted with the facility’s Clinical Manager (CM), who confirmed Staff Member B did not have the required current CPR certification and had been working at the facility with expired CPR certification. The CM stated Staff Member B was responsible for renewing the required CPR certification.”

“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: 39374 Based on observations, interviews, and policy review, the facility failed to ensure staff performed hand hygiene after glove removal when performing central venous catheter exit site care. The findings included: On 11/12/2024 at approximately 4:00 pm, an observation of central venous catheter (CVC) exit site care was conducted with Patient #8 and licensed practical nurse, Staff Member B. During the observation, Staff Member B brought several pairs of gloves and placed them, along with other supplies, on a clean pad on the chairside table for the purpose of performing CVC exit site care. Staff Member B removed and donned a new set of gloves after each step of the exit site care process which included removing the old dressing, cleansing the skin around the exit site, and placing the clean, sterile dressing over the exit site. Staff Member B did not wash hands or use alcohol-based hand rub (ABHR) after removing and before donning clean gloves after removing the soiled dressing, after cleansing the skin around the exit site, and before applying the clean, sterile dressing to the exit site. In an interview with Staff Member B immediately following the observation, stated that hand hygiene should have been performed between changing gloves but was not sure if there was a policy. When asked about availability of ABHR, Staff Member B went to the side of the dialysis machine where a pump dispenser of ABHR was located and depressed the pump but was unable to obtain enough ABHR to perform hand hygiene because the container was nearly empty. A review of the facility’s policy titled “Hand Hygiene” published 11/06/2023, reference number 47664, version 8, on page 1 of 6 included “Hands will be ... decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water ... immediately after removing gloves.””

“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: 45827 Based on observation, policy review and interview, the facility failed to ensure the Myron L Dialysate Meter (a medical device that tests the quality of dialysate for hemodialysis treatments) was calibrated in accordance with the manufacturer’s recommendations. The findings include: On 11/12/2024 at approximately 9:00 AM, a tour of the facility’s water room was conducted. A bottle of 4.0 pH (potential of hydrogen unit of measurement) Standard Buffer Solution (solution used to calibrate the Myron L Dialysate Meter) was observed without documentation of an open date or a discard date. The label on the front of the bottle instructed to discard 90 days after opening. A review of the facility’s Clinical Services Policy, Myron L D6 Meter Maintenance Procedures, Published 9/1/22, revealed on Page 1, #4, Discard expired solutions or solutions found without a cap. Use unexpired solutions for meter verification. On 11/13/24 at approximately 3:30 PM, an interview was conducted with the facility’s Biomed who stated the 4.0 pH Standard Buffer Solution should be labeled when opened and discarded 90 days after opening. He further stated there was no way to verify when the solution was opened since it was not listed on the bottle.”

“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: 39374 Based on record reviews, staff interviews, review of the facility’s policy and procedures and standing physician orders, the facility failed to provide the necessary care and treatment services to manage patients’ volume status, including documenting evidence of assessing and acting to address excessively high blood pressure measurements for 2 of 5 patients sampled for in-center hemodialysis (Patient #2 and Patient #4). The findings included: A review of the facility’s policy titled “Patient Assessment and Monitoring” published 05/01/2023, reference number 45284, version 4, on page 4 of 7 indicated “during treatment obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations.” The policy includes instructions to notify the nurse for an systolic blood pressure (SBP) greater than 180 mm Hg (millimeters mercury) and/or diastolic blood pressure over 100mmHg. The policy directs staff to ensure the “prescribed blood flow is being achieved or reason is documented in medical record if unable to achieve prescribed blood flow.” The post-treatment instructions indicated to “ensure vital signs and overall conditions are stable for discharge.” A review of “physician standing orders” titled “FKC Emeral Coast Standing Hemodialysis Orders v 6.3” included an “as needed” (PRN) order for Clonidine (an antihypertensive medication to lower blood pressure” written as “Clonidine: 0.1mg (milligram) PO (oral) if SBP (systolic blood pressure) is equal to or greater than 180 after the first hour of treatment. Repeat 0.1mg PO in 30 minutes if SBP remains equal to or greater than 180. Call MD for further instruction if SBP remains greater or equal to 180 30 minutes after second dose. If BP is greater than 220/110 give 0.1mg clonidine and notify MD/NP for further instruction. During an interview with the Director of Operations on 11/14/2024 at 11:53 AM, she confirmed the standing orders apply to all patients treated in the facility. A review of Patient #2’s treatment records reviewed for 10/29/2024, 10/31/2024, and 11/02/2024 included blood pressures exceeding the facility policy threshold of 170/100 (Systolic/diastolic) for over one hour from initiation of treatment which were not addressed in documentation and were not treated with Clonidine (a medication to lower blood pressure) per standing orders and were not reported to a nurse per policy on 11/02/2024. - On 10/29/2024, the pre-treatment blood pressure was 170/112 at 12:50 PM (Systolic/diastolic measured in millimeters Mercury). Treatment was initiated at 13:05 PM with a blood pressure of 171/110. The blood pressure measured at 14:09 PM was 177/106, repeated with the same result at 14:10 PM and there was no documentation of administration of Clonidine or any other action taken for the blood pressures noted at 14:09 PM and 14:10 PM which exceeded a diastolic pressure of 100mmHg after the first hour of treatment. - On 10/31/2024, the pre-treatment blood pressure was 198/115 at 12:29 PM (Systolic/diastolic measured in millimeters Mercury). Blood pressures measured during the treatment were as follows: 12:44 PM: 170/84; 13:02 PM: 190/103; 13:31 PM: 180/105; 14:01 PM: 181/92; 14:36 PM: 186/102; 15:10 PM: 179/102; 15:35 PM: 195/102. Patient #2 requested to terminate dialysis treatment early at 15:36 PM, completing 2 hours and 56 minutes of a prescribed 4-hour treatment time. Registered nurse (RN) G noted “patient encouraged to stay full treatment and educated to watch fluids. MD (medical director) notified.” There was no documentation of administration of medication per standing orders or notification of elevated blood pressures to MD. - On 11/02/2024, the pre-treatment blood pressure was 193/120 at 12:31 PM documented by patient care technician (PCT) F with no evidence that a nurse was notified of the elevated blood pressure. Blood pressures measured during the treatment were as follows: 12:41 PM: 203/121; 13:33 PM: 189/117; 14:02 PM: 213/95; 14:32 PM: 200/130 ; 15:01 PM: 219/128; 15:33 PM: 156/97. The PCT F documented the blood pressures taken from 12:31 PM through 14:02 PM with no documentation of notifying a nurse of the elevated blood pressures. RN H documented at 14:32 and the clinic manager who is an RN documented at 15:01 pm, with PCT F documenting the final intra-treatment blood pressure at 15:33 PM. The post-dialysis evaluation documented by PCT F at 15:53 PM included a blood pressure of 173/103. The nursing post-assessment documented at 16:39 PM by RN H noted “no unusual findings noted, patient tolerated treatment well, no complaints.” In addition to standing order protocols for the facility, the record for Patient #4 included an order dated 10/24/2024 by the facility’s medical director for “Clonidine HCl (hydrochloride) 0.1 mg oral PRN (as needed) - may repeat x 1 for systolic blood pressure greater than 180.” A review of Patient #4’s treatment record identified on 10/29/2024 multiple elevated blood pressures after the first hour of treatment with a systolic blood pressure greater than 180 for which no administration of Clonidine was documented. Three blood pressure measurements were recorded by PCT E that exceeded 170/100 with no documentation of nurse notification. These blood pressures were taken at 13:09 PM (165/102), 13:33 PM (171/104), and 16:28 PM (197/107). The documentation did not indicate any attempt to treat blood pressures with standing order medication or any discussion with medical doctor or nurse practitioner regarding the patient’s elevated blood pressures. The treatment record for 10/29/2024 included the following intra-dialytic blood pressures: 12:28 PM: 180/109; 13:09 PM: 165/102; 13:33 PM: 171/104; 14:05 PM: 170/92; 1:44 PM: 150/98; 15:03 PM: 174/97; 15:35 PM: 184/98; 16:06 PM: 193/108; 16:28 PM: 197/107. Post-treatment blood pressures 195/105 sitting and 179/101 standing documented at 16:26 PM by RN D, who documented the post-treatment assessment at 17:09 PM as “patient leaving 6.5kg (kilograms) under EDW (estimated dry weight). Sitting BP is 195/105, standing BP is 179/101. Patient denies chest pain, shortness of breath, nausea or headache. Patient refused emergency care for elevated BP, AMA signed. Patient instructed to seek emergency for any of the above symptoms, verbalized understanding.” - The treatment record for Patient #4 on 10/31/2024 again included blood pressures which reached the parameters for administration of Clonidine and no documentation of administration of medication was found. The treatment record included pre-dialysis evaluation blood pressures 184/114 sitting and 180/104 standing at 12:07 PM and the following intra-dialytic blood pressure readings: 12:21 PM: 169/; 13:03 PM: 174/109; 13:31 PM: 181/107; 14:05 PM: 162/100; 14:06 PM: 162/100; 14:34 PM: 160/96; 15:08 PM: 186/103. The post-treatment blood pressures noted as 184/99 sitting and 165/92 standing at 15:31 PM by RN G, who documented at 16:11 PM the “patient tolerated treatment well, left facility with no complaints. Patient escorted to scale. Patient left above EDW, Patient educated to watch fluids, MD notified.” On 11/02/2024 at 16:01 PM a blood pressure of 182/94 documented by PCT F with no nurse notification documented. Post-treatment vital signs documented by PCT F as 174/96 sitting and 167/101 standing at 16:27 PM with no documentation of addressing elevated blood pressures with no nurse notification documented. The post-dialysis nurse assessment by RN H at 16:42 PM noted “patient tolerated treatment well, no complaints.” - The treatment record for 11/05/2024 included pre-treatment blood pressures were 194/107 sitting and 181/108 standing at 12:13 PM. Blood pressures after an hour of treatment exceeded the 170/100 threshold and met the requirement for administration of Clonidine for systolic blood pressure greater than 180, but no documentation of administration of Clonidine was found. The blood pressures were 186/106 at 15:06PM, 190/123 at 16:03 PM, and 200/115 at 16:25 PM, documented by PCT C with no nurse notification. Post treatment vital signs documented by PCT C at 16:26 PM were 197/100 sitting and 203/105 standing. Documented “no unusual findings noted post-assessment. Patient tolerated treatment well, no complaints.” - On 11/07/2024, pre-treatment blood pressures were 188/106 sitting and 185/101 standing at 12:05 PM and remained elevated throughout the treatment, with blood pressures greater than 170/100 noted after an hour of treatment with no administration of Clonidine to treat the blood pressures and no MD notification documented. The blood pressures were as follows: 12:17 PM: 184/104 ;2:33 PM: 167/103; 13:05 PM: 167/98; 13:35 PM: 160/96; 14:02 PM: 174/98; 14:30 PM: 184/106; 15:00 PM: 179/109; 15:33 PM: 191/106; 16:13 PM: 176/101. Post-dialysis readings were 180/92 sitting, 171/92 standing at 16:14 PM and RN G documented, “Patient tolerated treatment well, no complaints, hemostasis achieved, dressing dry and intact. Patient escorted to scale.” - Patient #4’s treatment record for 11/09/2024 also contained several elevated blood pressures, exceeding 170/100 for which no Clonidine was administered to treat, a PCT documented the reading with no nurse notification, and no MD notification throughout the treatment. The blood pressure readings are as follows: 13:04 PM: 166/102 - documented by PCT F; 13:33 PM: 177/103 - documented by PCT F; 14:02 PM: 164/101; 14:41 PM: 175/103 - documented by PCT F; 15:06 PM: 173/105 - documented by PCT F; 15:31 PM: 175/101 - documented by PCT F; 16:02 PM: 170/104 - documented by PCT F; 16:15 PM: 180/85. The post-dialysis blood pressures were 186/109 sitting; 180/107 standing documented by PCT F. Post assessment note documented at 16:42 PM by RN A: “No unusual findings. Treatment completed. Patient tolerated well. Vital signs stable. Hemostasis achieved. Patient had cramping at end of treatment. Patient 0.6 from EDW. Patient left dialysis unit via ambulation. Next scheduled treatment is Tuesday. (11/12/2024)” During an interview on 11/13/2024 at 3:30PM, the Clinic Manager reviewed Patient #2’s record and agreed the elevated blood pressures should have been addressed and said that if no documentation of medication administration is in the treatment record, there is no where else in the record it would be located. The Clinic Manager confirmed that if the medication administration was not documented it was not given. During an interview with the Medical Director (MD) on 11/14/2024 at 9:30AM, the MD was asked about the elevated blood pressures for patients #2 and #4 and said that he was not notified of those blood pressures and they need to be addressed.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 39374 Based on record review, policy review, and interview, the facility failed to ensure prescribed blood flow rates were followed during dialysis for one of five patients sampled for in-center hemodialysis (Patient #2). The findings included: The treatment record for Patient #2 on 11/02/2024 idicated the blood flow rate was ordered at 350 ml (milliliters) per minute but was set at 200 ml during treatment from 12:41 PM (initiation of treatment) until 15:33PM and treatment was terminated at 15:53PM. There was no indication why the prescribed blood flow rate was not followed. A review of policy titled “Patient Assessment and Monitoring” published 05/01/2023, reference number 45284, version 4, on page 4 of 7 included directions for staff to “check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow.” During an interview on 11/13/2024 at 3:30 PM, the Clinic Manager reviewed Patient #2’s record and noted that Patient #2 had a blood flow rate of 200 during the treatment on 11/02/2024 instead of the prescribed blood flow rate of 350. The clinic manager explained the blood flow rate is related to the patient’s dialysis access which has needed to be replaced recently and is hard to keep flowing, and that a note providing a reason for not following the dialysis prescription for a blood flow rate of 350 should have been documented.”