Fmc Lumberton Dialysis Unit

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 38766 Based on facility policy review, observations, and staff interviews, the facility failed to separate clean areas from contaminated areas where non-disposable vascular access clamps were stored to prevent cross-contamination in 1 of 1 observed storage of cleaned vascular access clamps and scissors ready for patient use (behind Bay A and Bay B). Findings included: Review of current facility policy and procedure on 11/14/2023 “Dialysis Precautions” (Effective 01/04/2012)”... Clean Versus Dirty Areas - Clean area: An area designated for clean and unused equipment, supplies, and medications. Dirty Area: An area where there is a potential for contamination with blood or body fluids and areas where contaminated or used supplies, equipment, blood supplies, or biohazardous containers are stored or handled. Clean areas should be clearly designated for the preparation and handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from dirty areas where used supplies, equipment, or blood samples are handled or stored...” Observation on 11/14/2023 between 1030 and 1150 in the patient treatment area revealed clean clamps and scissor clamps (non-disposable equipment) were placed in an uncovered plastic container at a clean hand washing sink (labeled) located in Bay A and Bay B of the facility. The observation revealed the clamps and scissor clamps were placed directly beside the handwashing sink and under a paper towel dispenser where the potential for cross-contamination existed by water splattering during times of staff hand washing. An interview on 11/16/2023 at 1355 with the Clinical Manager revealed most of the staff have been at the clinic for a long time and know that the clean clamps and scissor clamps should not be stored where there is a risk for cross-contamination during hand washing. The interview confirmed the observation finding and the Clinical Manager will conduct reeducation of the staff.”

“ACID BULK STORAGE TANKS-SAFETY CONTROLS CFR(s): 494.40(a) 5.4 Concentrate preparation 5.4.3 Bulk storage tanks (acid concentrate): safety controls Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. This Standard is not met as evidenced by: 38766 Based on facility policy and procedures, observations, and staff interviews, the facility staff failed to ensure that acid concentrates 55-gallon drums were kept tightly sealed to prevent potential contamination in 2 of 9 observed acid concentrate 55-gallon drums. Findings included: A review on 11/15/2023 of the facility policy titled “Acid Concentrate Storage and Handling,” published 07/03/2023 revealed “ ...55-Gallon Drums: 55-gallon drums with a drum pump installed must have the pump threaded securely into the drum opening. Replace drum cap(s) after the drum is empty or if the pump is not installed...” Observation on 11/15/2023 at 1015 in the supply room area revealed a total of nine (9), fifty-five (55) gallon acid concentrate drums. One (1) of the 55-gallon acid concentrate drums for the acid formula of 3251 (3.0 K [potassium], 2.5 CA [Calcium]) had an acid pump stored inside of the top port opening that was not threaded securely while not in use, and another drum for the acid formula of 2205 (2.0 K, 2.0 CA) had the top port cap/lid removed from the top port openings. The observation revealed no staff members were in the supply storage area and using the pump at the time of the observation. An interview on 11/15/2023 at 1015 with the Biomedical Technician during the observation revealed the 55-gallon drums should be capped when they were not in use. The process was for the staff to remove the pump out and capped the drums. The interview revealed, “I (Biomedical Technician) will get with the Clinical Manager to try to fix that.” An interview on 11/16/2023 at 1355 with the Clinical Manager revealed that the pump should not be left in the 55-gallon drums. The process was for the staff to remove the pump and close the drums. “The clinic will come up with a plan on what to do with the pump when not in 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: 38766 Based on facility policy review, medical records, and staff interviews, the facility staff failed to perform and/or document every 30-minute monitoring of patients during dialysis treatments for 5 of 9 patient records reviewed (Patient #8, #7, #3, #1, and #9). Findings included: A review on 11/14/2023 of the facility policy titled, “Patient Assessment and Monitoring” revised 05/01/2023, revealed “...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. Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulations...” 1. Medical record review on 11/16/2023 of patient #8 revealed a 35-year-old female patient admitted on 06/11/2022 for in-center hemodialysis treatment. The review of the treatment sheet for 11/01/2023 revealed patient #8 had an HD treatment from 1236 through 1637. The review of the treatment sheet revealed no documented vital signs from 1428 through 1638 (130 minutes). The review of the treatment sheet for 11/03/2023 revealed patient #8 had an HD treatment from 1241 through 1641. The review of the treatment sheet revealed no documented vital signs from 1422 through 1522 (60 minutes). The review revealed the facility staff failed to follow the policy. An interview on 11/16/2023 at 1355 with the Clinical Manager revealed that the dialysis machines were set to obtain the patient’s blood pressure and pulse every 20 minutes. The staff have been educated to document the patient’s vital signs at a minimum of 30 to 45 minutes per the policy. The interview revealed that “the issue was the staff not documenting the vitals and performing safety checks.” 2. Medical record review on 11/15/2023 of patient #7 revealed a 64-year-old female patient admitted on 06/20/2023 for in-center hemodialysis treatment. The review of the treatment sheet for 11/04/2023 revealed patient #7 had an HD treatment from 1052 through 1404. The review of the treatment sheet revealed no documented vital signs from 1200 through 1404 (124 minutes). The review of the treatment sheet for 11/09/2023 revealed patient #7 had an HD treatment from 1040 through 1405. The review of the treatment sheet revealed no documented vital signs from 1041 through 1156 (75 minutes). The review revealed the facility staff failed to follow the policy. An interview on 11/16/2023 at 1355 with the Clinical Manager revealed that the dialysis machines were set to obtain the patient’s blood pressure and pulse every 20 minutes. The staff have been educated to document the patient’s vital signs at a minimum of 30 to 45 minutes per the policy. The interview revealed that “the issue was the staff not documenting the vitals and performing safety checks.” 3. Medical record review on 11/16/2023 of patient #3 revealed a 46-year-old female patient admitted on 10/17/2022 for in-center hemodialysis treatment. The review of the treatment sheet for 11/03/2023 revealed patient #3 had an HD treatment from 1217 through 1622. The review of the treatment sheet revealed no documented vital signs from 1349 through 1550 (121 minutes). The review revealed the facility staff failed to follow the policy. An interview on 11/16/2023 at 1355 with the Clinical Manager revealed that the dialysis machines were set to obtain the patient’s blood pressure and pulse every 20 minutes. The staff have been educated to document the patient’s vital signs at a minimum of 30 to 45 minutes per the policy. The interview revealed that “the issue was the staff not documenting the vitals and performing safety checks.” 4. Medical record review on 11/14/2023 of patient #1 revealed a 39-year-old female patient admitted on 09/14/2023 for in-center hemodialysis treatment. The review of the treatment sheet for 10/31/2023 revealed patient #1 had an HD treatment from 1127 through 1530. The review of the treatment sheet revealed no documented vital signs from 1353 through 1458 (65 minutes). The review of the treatment sheet for 11/04/2023 revealed patient #1 had an HD treatment from 1132 through 1531. The review of the treatment sheet revealed no documented vital signs from 1250 through 1400 (70 minutes). The review of the treatment sheet for 11/09/2023 revealed patient #1 had an HD treatment from 1139 through 1539. The review of the treatment sheet revealed no documented vital signs from 1350 through 1459 (69 minutes). The review of the treatment sheet for 11/11/2023 revealed patient #1 had an HD treatment from 1029 through 1431. The review of the treatment sheet revealed no documented vital signs from 1226 through 1323 (57 minutes). The review revealed the facility staff failed to follow the policy. An interview on 11/16/2023 at 1355 with the Clinical Manager revealed that the dialysis machines were set to obtain the patient’s blood pressure and pulse every 20 minutes. The staff have been educated to document the patient’s vital signs at a minimum of 30 to 45 minutes per the policy. The interview revealed that “the issue was the staff not documenting the vitals and performing safety checks.” 5. Medical record review on 11/16/2023 of patient #9 revealed a 65-year-old female patient admitted on 10/24/2019 for in-center hemodialysis treatment. The review of the treatment sheet for 11/01/2023 revealed patient #9 had an HD treatment from 1046 through 1448. The review of the treatment sheet revealed no documented vital signs from 1222 through 1326 (64 minutes). The review of the treatment sheet for 11/03/2023 revealed patient #9 had an HD treatment from 1039 through 1440. The review of the treatment sheet revealed no documented vital signs from 1040 through 1156 (76 minutes). The review revealed the facility staff failed to follow the policy. An interview on 11/16/2023 at 1355 with the Clinical Manager revealed that the dialysis machines were set to obtain the patient’s blood pressure and pulse every 20 minutes. The staff have been educated to document the patient’s vital signs at a minimum of 30 to 45 minutes per the policy. The interview revealed that “the issue was the staff not documenting the vitals and performing safety checks.””

“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: 38766 Based on policy review and direction for use, observations, and staff interviews, the facility staff failed to maintain glucose test strips and the glucose control solution according to facility policies for 1 of 1 container of test strips and glucose control solutions (high and low solutions). Findings included: A review on 11/14/2023 of the facility policy “Blood Glucose Monitoring Device” effective 11/06/2023 revealed, “...Calibration and Quality Control Testing ...Monitor expiration date of calibrating solution...” A review on 11/14/2023 of the “EmbracePro Blood Glucose Monitoring System Quality Assurance/Quality Control Reference Manual” revealed, “...Use by dates: Test strips must be discarded by the expiration date. Count forward four months from the date that you open a new vial of EmbracePRO Test Strips. This is the discard date... The control solution must be discarded by either the expiration date or the discard date, whichever comes first. Count forward 90 days from the date that you open a new bottle of EmbrocePRO Control Solution. This is the discarded date. Write the discard date on the EmbrocePRO Control Solution bottle...” Observation on 11/14/2023 from 1030 through 1140 of the treatment areas revealed a designated lab area. Observation of the lab area revealed a drawer that contained a glucometer, two bottles of glucose control solutions (high and low), and a bottle of test strips. The observation revealed the bottles of the control solutions, and the bottle of test strips were not marked with the opened and discarded dates, and the initials of the teammate who opened the bottles. An interview on 11/14/2023 at 1140 with PCT #3 during the observation revealed that the bottles were supposed to be dated and initialed. The interview revealed “I did date and initialed the boxes, but the boxes got thrown away. I should have put the date and my initials on the bottles.” An interview on 11/16/2023 at 1355 with the Clinical Manager revealed that “the staff know that the test strips and the control solutions should be discarded when they are expired but they would not know when they are expired if they do not document the date on the bottles.”