Fresenius Medical Care Fairfield County

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 41743 Based on interview and record review, the dialysis facility failed to provide documentation for oversight and management of the Emergency Preparedness Plan (EPP) by the governing Body. Findings include: Record review of facility EPP on 5/02/2024 at 10:24 AM revealed no documentation of Governing Body review and/or approval of the EPP since 6/27/2018. During an interview on 5/02/2024 at 10:55 AM, the Director of Operations stated, We will try to locate the documentation”.”

“Development of Communication Plan CFR(s): §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This Standard is not met as evidenced by: 41743 Based on interview and record review, the dialysis facility failed to provide documentation for review of the emergency preparedness communication plan by the governing body. Findings include: Record review of the facility Emergency Preparedness Plan (EPP) on 5/02/2024 at 10:24 AM revealed no documentation of Governing Body review and/or approval of the EPP communication plan since 6/27/2018. During an interview on 5/02/2024 at 10:55 AM, the Director of Operations stated, “We will try to locate the documentation”.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 41743 Based on interview and record review, the dialysis facility failed to provide documentation for review of testing and training of the Emergency Preparedness Plan (EPP) by the governing Body. Findings include: Record review of the facility EPP on 5/02/2024 at 10:24 AM showed that there is no documentation of Governing Body review and/or approval of the EPP testing or training plans since 6/27/2018. During an interview on 5/02/2024 at 10:55 AM, the Director of Operations stated, “We will try to locate the documentation”.”

“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: 41743 Based on observation and interview, the dialysis facility staff failed to perform hand hygiene in a clean sink, exposing patients to possible infection by Patient Care Technician (PCT # 3). Findings include: Observation of the treatment floor on 05/01/2024 at 11:10 AM revealed PCT #3 seen washing his/her hands in a sink labeled as “Dirty”. During an interview on 05/02/2024 at 11:13 AM, the Director of Operations (DO) stated he/she was surprised by this observation.”

“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: 41743 Based on observation, interview and review of facility policy and procedure, the dialysis facility failed to ensure expired supplies were removed from the patient treatment area and that medications on the treatment area were secured properly. Findings include: Observations on 4/29/2024 at 10:30 AM to 12:00 PM of the medication area revealed the medications in the storage area in Bay A and B were unlocked and unsupervised with (9) 16 gauge needle sets expired on 3/31/2024. Facility policy, entitled “Storage of Supplies and Supply Expiration Dates for Inpatient Services”, revealed “Expired supplies will be removed and disposed of properly”. Observation on 4/30/2024 between 11:00 AM and 12:30 PM revealed the medication storage area for Bays A and B drawers were unlocked and unsupervised by the Director of Operations (DO), the dialysis nurse for the patients for the day. Observation on 5/01/2024 from 10:30 AM to 12:05 PM revealed the medication storage area drawers in Bay B were unlocked with (6) labeled medication syringes unsecured and unsupervised on a countertop. During an interview on 5/02/2024 at 11:13 AM, the Director of Operations (DO) stated he/she was unaware of this requirement. Facility policy entitled “Medication Preparation and Administration” revealed, “Medication should be secured in locked cabinets and not left unattended”.”

“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: 41743 Based on observation, interview and review of Manufacturer’s Instructions (MI), the dialysis facility staff failed to follow the manufacturer instructions regarding the storage of the Myron D6 meters when not in use. Findings include: Review of MI instructions, entitled “Digital Dialysate Meter Operation Manual”, dated 2/16/2018 revealed “The pH meter should always be capped and after each use kept wet with pH sensor solution”...”. Observation on 4/29/2024 of the treatment room floor at 10:30 AM to 12:00 PM revealed (3) Myron D6 Meters on the treatment floor left uncapped and open to air. Observation on 4/30/2024 of the treatment room floor at 11:20 AM revealed Registered Nurse (RN) #3 and RN #2 used the Myron D6 meter to test pH dialysate levels prior to the initiation of a patient treatment and failed to instill solution into the pH sensor well post usage prior to capping. Observation on 4/30/2024 of the treatment room floor at 12:18 PM revealed RN #1 and Patient Care Technician (PCT) #5 used the Myron D6 meter to test pH dialysate levels prior to the initiation of a patient treatment and failed to instill solution into Ph sensor well post usage prior to capping. Observation on 5/01/2024 of the treatment room floor at 11:06 AM revealed RN #1 and PCT #4 used the Myron D6 meter to test pH dialysate levels prior to the initiation of a patient treatment and failed to instill solution into the pH sensor well and/or cap the well post usage. During an interview on 5/02/2024 at 10:55 AM, the Director of Operations stated that he/she was unaware of instructions to add solution to the pH well after each use.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 41743 Based on record review, interview and review of facility policy and procedure, the dialysis facility staff failed to ensure blood pressure (BP) checks were completed every 30 minutes for 5 out of 7 patient charts reviewed. (Patient #1, #2, #3, #4 and #7). Findings include: Review of Patient #1’s medical record on 4/30/2024 at 1:30 PM revealed on 4/10/2024 a BP reading of 176/81 at 11:36 AM with the next BP reading of 167/87 at 12:30 PM which was 54 minutes between readings. During an interview on 5/01/2024 at 9:17 AM, the Director of Operations (DO) stated, “Vital signs should be checked every 30 minutes” and verified the finding. Review of Patient #2’s medical record on 4/30/2024 at 9:37 AM revealed on 4/11/2024 a BP reading of 165/95 at 7:00 AM with the next BP reading of 166/93 at 7:54 AM which was 54 minutes between BP checks. On 4/13/2024 at 8:34 AM a BP reading of 159/88 with the next BP reading at 9:35 AM of 164/96 which was 61 minutes between BP checks. On 4/16/2024 at 7:25 AM a BP reading of 174/99 with the next BP reading of 177/110 at 8:25 AM which was 60 minutes between BP checks. On 4/23/2024 a BP reading of 166/88 at 9:00 AM with the next BP reading of 163/94 at 11:39 AM which was 2 hours and 39 minutes between BP checks. On 4/25/2024 at 8:32 AM a BP reading of 156/94 with the next BP reading of 157/87 at 9:37 AM which was 65 minutes between BP checks. On 4/27/2024 BP checks. During an interview on 5/01/2024 at 9:25 AM, the DO verified the findings. Review of Patient #3’s medical record on 4/30/2024 at 8:45 AM revealed on 4/17/2024 a BP reading of 129/72 at 8:33 AM with the next BP reading of 110/69 at 9:39 AM which was 66 minutes between BP checks. During an interview on 5/01/2024 at 9:15 AM, the DO verified the finding. Review of Patient #4’s medical record on 4/30/2024 at 12:50 PM revealed on 4/16/2024 at 1:30 PM a BP reading of 136/74 with the next BP reading of 135/78 at 2:47 PM which was 87 minutes between BP checks. On 4/23/2024 at 11:09 AM a BP reading of 152/73 with the next BP reading of 143/68 at 12:35 PM which was 1 hour and 26 minutes between BP checks. During an interview on 5/01/2024 at 9:02 AM, the DO verified the findings. Review of Patient #7’s medical record on 4/30/2024 at 10:20 AM revealed on 4/12/2024 at 2:41 PM a BP reading of 132/70 with the next BP reading of 128/68 at 3:35 PM which was 54 minutes between readings. On 4/22/2024 at 1:03 PM a BP reading of 156/84 with the next BP reading of 138/86 at 2:03 PM which was 60 minutes between BP checks. During an interview on 5/01/2024 at 9:07 AM, the DO verified the findings. Facility policy, entitled, “Patient Assessment and Monitoring” revealed, “Staff instructed to monitor BP every 30 minutes not to exceed 45 minutes”.”