Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 012515	(X3) Date Survey Completed 04/20/2023
Name of Provider or Supplier Fresenius Medical Care Opelika	Street Address, City, State 2609 Village Professional Drive, Suite 2, Opelika, AL
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.

(X4) ID Prefix Tag

Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)

V0543

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:
Based on review of medical records (MR), facility policies, facility "Recommended Volume Evaluation and Management Algorithm Version 2.0", and interviews with the staff, it was determined the facility failed to ensure: 1. The physician was notified of the patient leaving greater than 1.0 kg (kilograms) over the EDW (Estimated Dry Weight). 2. Normal Saline (NS) used for prime and post treatment rinse was documented. 3. Staff notified the nurse/physician with elevated BP (blood pressures) and administered ordered prn (as needed) Clonidine. This deficient practice affected six of seven in-center hemodialysis records reviewed and did affect Patient Identifier (PI) # 8, PI # 9, PI # 10, PI # 2, PI # 4, PI # 3, and had the potential to negatively affect all patients dialyzing at this facility. Findings include: Recommended Volume Evaluation and Management Algorithm Version 2.0 Date: 2019 Goal: Patient's post treatment will be less than 1 kg from EDW without signs or symptoms of hypervolemia or hypovolemia. ...6. EDW Assessment ...No sign or symptoms of hyper/hypovolemia... consult physician for new EDW. Facility Policy: Patient Assessment and Monitoring Published: 09/29/18 Version 3 Pre-Treatment Assessment and Data Collection Pre-Treatment: Direct patient care staff may collect pre-treatment weight, BP (blood pressure), pulse, respirations, temperature, general observations, access, and complaints reported by the patient. ...any changes or abnormal findings in patient's condition or vascular access are observed...the patient care technician (PCT) MUST report the changes in the patient condition to a registered nurse who will further assess the patient prior to initiation of the treatment. An abnormal finding confirmed by the RN (Registered Nurse) will be reported to the attending physician for assessment and intervention if necessary... During Treatment The RN will assess/re-assess any findings addressed pre or during treatment as needed... Follow the steps below for obtaining pre-treatment assessment data: 1. The direct care staff may obtain the following data: Weight: Record pre-weight. Compare pre-weight to estimated dry weight. Post-Treatment: ...The staff member who collects the information and evaluates the patient post-treatment will document their findings on the hemodialysis treatment record... any changes or abnormal findings in the patient's condition, vital signs or vascular access are observed...must report the changes in the patient condition to a RN who will further assess the patient prior to discharge... An abnormal finding confirmed by the RN will be reported to the attending physician... Monitoring During Treatment ...Record BP...to the nurse: Systolic BP's greater than 180 mm/Hg (millimeters/mercury) Diastolic BP greater than 100 mm/Hg... Post-Treatment Follow the steps below for obtaining post-treatment assessment data: 1. The direct care staff may obtain the following data: Assessment and Data Collection Weight: obtain the patient's post weight. Ensure the post weight is consistent with the goals set of the machine... Facility Policy: Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer. Published: 7/6/21 Version 5 Prior to Initiation: Assessment and Treatment Parameters. Follow the steps below to assess the patient, calculate the UF (ultrafiltration) goal and enter the prescribed treatment parameters: ...6. Add any fluids to be given during the treatment such as, saline prime/rinse back...during treatment... 1. PI # 8 was admitted to the facility on 9/14/2020 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Sheet (TS) dated 4/14/23 revealed there was no documentation of the NS amount used for the rinse back at the end of the treatment. An interview was conducted on 4/19/23 at 11:27 AM with Employee Identifier (EI) # 2, Director of Operations (DOO), Sister Facility, who confirmed the staff failed to document the amount of NS used for rinse back at the end of treatment. 2. PI # 9 was admitted to the facility on 5/3/22 with diagnoses including ESRD. Review of the Order Summary Report (OSR) revealed Hemodialysis (HD) orders dated 2/9/23 which included EDW 115 kg. Review of the TS dated 4/6/23 revealed a pre-treatment weight of 125.0 kg and a post-treatment weight of 122.0 kg, which was 7.0 kg above the EDW. There was no documentation the physician was notified of the patient's post-treatment weight 7.0 kg above the ordered EDW. Review of the TS dated 4/8/23 revealed a pre-treatment weight of 119.7 kg and a post-treatment weight of 117.2 kg, which was 2.2 kg above the EDW. There was no documentation the physician was notified of the patient's post-treatment weight 2.2 kg above the ordered EDW. Review of the TS dated 4/11/23 revealed a pre-treatment weight of 123.3 kg and a post-treatment weight of 120.0 kg, which was 5.0 kg above the EDW. There was no documentation the physician was notified of the patient's post-treatment weight 5.0 kg above the ordered EDW. Review of the TS dated 4/13/23 revealed a pre-treatment weight of 125.0 kg and a post-treatment weight of 121.0 kg, which was 6.0 kg above the EDW. There was no documentation the physician was notified of the patient's post-treatment weight 6.0 kg above the ordered EDW. Review of the TS dated 4/15/23 revealed a pre-treatment weight of 120.7 kg and a post-treatment weight of 117.0 kg, which was 2.0 kg above the EDW. There was no documentation the physician was notified of the patient's post-treatment weight 2.0 kg above the ordered EDW. Review of the TS dated 4/18/23 revealed a pre-treatment weight of 124.6 kg and a post-treatment weight of 121.4 kg, which was 6.4 kg above the EDW. There was no documentation the physician was notified of the patient's post-treatment weight 6.4 kg above the ordered EDW. An interview was conducted on 4/19/23 at 3:15 PM with EI # 2 who confirmed there was no documentation the physician was notified of the patient post-treatment weights above the ordered EDW on 4/6/23, 4/8/23, 4/11/23, 4/13/23, 4/15/23 and 4/18/23. 3. PI # 10 was admitted to the facility on 8/6/2020 with diagnoses including ESRD. Review of the TS dated 4/13/23 revealed no documentation of the NS amount used for the prime administration at the beginning of the treatment. An interview was conducted on 4/19/23 at 11:27 AM with EI # 2 who confirmed the staff failed to document the amount of NS used for prime administration at the beginning of treatment. 41624 4. PI # 2 was admitted to the facility on 1/6/23 with a diagnosis of ESRD. Review of the TS dated 4/12/23 revealed no documentation of the NS amount used for the rinse back at the end of the treatment. An interview was conducted on 4/20/23 at 10:00 AM with EI # 1 who confirmed the staff failed to document the amount of NS used for rinse back at the end of treatment. 30952 5. PI # 4 was admitted to the facility on 12/27/22 with a diagnosis of ESRD. Review of the OSR revealed treatment medications included Clonidine HCL (Hydrochloride) (for treatment of elevated BP) 0.2 mg (milligram) oral prn, start date 1/12/23. Review of the TS dated 4/11/23 revealed the nurse documented the pre-treatment BP sitting 143/81 at 11:10 AM. Further review of the 4/11/23 TS revealed the PCT documented the following elevated BP's: At 11:37 AM BP 173/104 At 12:03 PM BP 170/103 At 12:35 PM BP 180/110 At 1:42 PM BP 160/101 At 2:00 PM BP 171/100 There was no documentation the staff notified the nurse when the diastolic BP was greater than 100 mg/Hg. There was no documentation prn Clonidine was administered when the diastolic BP was greater than 100 from 11:37 AM until 2:00 PM. Review of the TS dated 4/15/23 revealed the nurse documented at 10:02 AM the pre-treatment BP sitting 212/127, at 10:14 AM treatment start time BP 221/123, at 10:33 AM BP 218/123, and 11:02 AM BP 198/117, which was greater than 180 systolic and 100 diastolic. There was no documentation the physician was notified of the BP's above 180 systolic and 100 diastolic. There was no documentation the nurse offered and administered prn Clonidine. Further review of the 4/15/23 TS revealed at 11:33 AM the PCT documented BP 180/110, and at 12:05 PM the BP was 179/106. There was no documentation staff notified the nurse the diastolic BP was greater than 100. An interview was conducted on 4/19/23 at 2:45 PM with EI # 2, who confirmed the staff failed to notify the nurse/physician of systolic BP greater than 180 and diastolic greater than BP 100. There was no documentation prn Clonidine was offered/administered. 6. PI # 3 was admitted to the facility on 11/29/19 with diagnoses including ESRD. Review of the TS dated 4/14/23 revealed no documentation of the NS amount used for the rinse back at the end of the treatment. An interview was conducted on 4/19/23 at 3:53 PM with EI # 1, who confirmed the staff failed to document the amount of NS used for rinse back at the end of treatment.