Fmc Orangeburg Dialysis

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 28883 Based on observation, interview, and review of the policy “Hand Hygiene”, the dialysis clinic nursing staff failed to ensure cross contamination did not occur after two of two random patients observed failed to perform hand hygiene after holding needle sites, and touched the handrail and/or doorknob. The findings included: Observation on 4/8/24 between 1:08 PM and 1:32 PM revealed a patient at machine 2, station 10. The patient had finished dialysis treatment and was holding pressure to the needle sites to stop the bleeding with a gloved hand. At 1:32 PM, Registered Nurse #1 assisted the patient to removed the glove; and reinforced tape over the gauze on the needle sites. The nurse did not offer, and the patient did not perform hand hygiene. The patient placed items in a bag, while the nurse got another blood pressure. At 1:48 PM, the nurse took a standing blood pressure. The nurse then assisted the patient to the scale where the nurse got a weight while the patient held onto the railing. The patient exited the treatment room without performing hand hygiene. The finding was reviewed with RN #1 during an interview on 4/8/24. Observation on 4/8/24 between 11:58 AM and 12:04 PM revealed Patient Care Technician (PCT) #1 pulling tape and the 2nd needle from a patient’s arm at machine 19, station 9. The patient held pressure to the needle site(s) with a gloved hand. At 12:05 PM, the technician removed the patient’s glove. The patient picked up a cell phone, put on a jacket, picked up a bag, weighed himself/herself, and left the treatment area touching the doorknob. The patient had not been offered/instructed to perform hand hygiene; and did not perform hand hygiene before leaving. The observation was reviewed and finding verified during an interview on 4/8/24 with PCT #1. Review on 4/9/24 at 2:00 PM of the policy provided by the dialysis clinic entitled “Hand Hygiene” revealed hands would be decontaminated with alcohol-based hand rub or by washing hands with antimicrobial soap and water on entering and leaving the treatment area; after contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled; and immediately after removing gloves.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 28883 Based on observation, interview, and review of the clinic policy/Best Practice inservice information for the CryoDose Topical Anesthetic Spray, the dialysis clinic failed to ensure unlicensed Patient Care Technicians did not use the Cryodose anesthetic spray on patients, that patients had physician orders for the use of the anesthetic spray, and that training had been documented for licensed healthcare providers related to the use of the spray. The dialysis clinic failed to ensure the CryoDose spray was stored appropriately and had given the spray to patients to take home and bring back to the clinic for their treatment. The findings included: Observation on 4/9/24 at 8:58 AM revealed Patient Care Technician (PCT) #2 at station 2, machine 1, preparing Patient #8 for a dialysis treatment. The technician cleaned the patient’s skin over the access site with alcohol, and then sprayed CryoDose topical anesthetic spray over the site. The technician stuck the first dialysis needle in and taped it in place. The technician did the same prep for the 2nd needle site before sticking the 2nd needle in. Observation on 4/9/24 at 9:03 AM of information on the CryoDose anesthetic spray container revealed it was a skin refrigerant for use on skin to temporarily control pain associated with injections, starting IVs, Venipuncture, minor surgery, and minor athletic injuries. It included information “..Caution. Federal USA law restricts this device to sale by, the order of, or use by a licensed Healthcare Practitioner. Note: This product is a medical device and not a drug.” After reviewing the information and giving the container back to the technician; PCT #2 stated that Patient #8 takes the CryoDose spray container with him/her from home to the clinic (for staff to use) and back home. During an interview 4/9/24 at 9:26 AM, PCT #2 stated that several patients had orders for the anesthetic spray and that Patient #8 had just recently been getting the anesthetic spray. When asked how s/he knew the patient had orders for the spray; the technician pulled up the patient in the computer system, but was unable to find orders or any other documentation that indicated the CryoDose or other anesthetic spray was to be used for the patient. During an interview on 4/9/24 at 9:33 AM, Registered Nurse (RN) #1 stated that the CryoDose anesthetic spray bottles come from Fresenius (Corporate). Since the EMLA cream was on back order, the nursing staff gives patients that want it a can of the CryoDose spray. Nurses or Patient Care Technicians administer the spray. When asked if s/he had undergone any special training related to the use of the spray, RN #1 stated no, then said they had an inservice maybe a few months ago. RN #1 and the surveyor then pulled up Patient #8’s chart to review it for any orders or special attentions/documentation related to the use of the CryoDose anesthetic spray and there were none. Record review on 4/11/24 at 10:43 AM of the physician orders, nurses’ notes, and the dialysis treatment sheet dated 4/9/24 for Patient #8 revealed nothing documented related to the CryoDose spray or that patient education had been provided. During an interview on 4/11/24 at 11:01 AM, the Administrator stated that the nursing staff had been inserviced on the CryoDose spray, but it had not been documented. According to the Administrator, six patients (including Patient #8) had been given the CryoDose spray cannisters to store at home. Review of the inservice information “Best Practice-CryoDose Mist Spray” and the policy “CryoDose TA Topical Anesthetic Spray”, revealed information to “Obtain Provider order for Cryodose. Enter as special attention order. Clinical staff prepare access for cannulation per policy...Label the cannister with the patient’s name. Review Cryodose information with patient. NOTE: If the skin turns white or blanches, stop spraying”. Under Patient Talking Points was information that “....EMLA cream is no longer available...You will be given the CryoDose cannister to take home and bring back to the clinic for your treatment. Do not use at home. Keep out of the reach of children. Do not expose to heat. Store at room temperature in your home...”.”