Fresenius Medical Care Hawks Nest

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 38282 Based on observation, documentation review, and staff interview, the facility failed to ensure the proper procedures were utilized during a pre-treatment lab draw in order to prevent infection for one (1) of one (1) patient (Patient #6) observed having bloodwork drawn from a CVC [central venous catheter]. This failure has the potential to affect all patients receiving lab draws at the facility. Cross Reference: 494.30 (a)(4) Standard: Procedures for Infection Control Findings are as follows: A review of the policy, titled “Drawing Blood Work Pre-Treatment from an AVF/AVG [arteriovenous fistula/arteriovenous graft] or Catheter;” dated 05/02/22; stated, in part, “All bloodwork will be obtained following the same processes to ensure consistency and accuracy of the results.” The procedure for drawing the bloodwork from the CVC was reviewed but did not include re-instilling the blood waste. A review of the policy, titled “Hand Hygiene” dated 11/06/23; stated, in part, “Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water. When: ... Entering and leaving the treatment area ... After contact with other objects within the patient station or treatment space.” An observation was conducted on 04/08/24 starting at 12:15 p.m. of Patient #6 at Station #1. Employee #1 was accessing the venous catheter for a pre-treatment lab draw prior to the initiation of dialysis. Employee #1 sanitized their hands, donned gloves, placed a barrier under the CVC, and flushed the port with ten milliliters (10 ml) of saline. Employee #1 stated: “Oh! I need to draw labs.” Then Employee #1, without removing the gloves, left station #1 and went to the nurses station, located diagonal to station #1, and was handed a 10 cc [cubic centimeter] syringe per request. Employee #1 returned to station #1, and without removing her gloves and sanitizing her hands, pulled 10 ml of “waste” blood into the syringe. Employee #1 laid the uncapped syringe of blood on the barrier, placed the vacutainer on the port and obtained the sample for testing, and picked up the syringe of blood and reinstalled it into the catheter. Dialysis was then initiated. An interview was conducted on 04/09/24 at 9:05 a.m. with Employee #2, who confirmed that at no time was “waste” blood to be re-instilled because of the increased risk of infection. Employee #2 stated that an adverse event report was going to be placed and staff required retraining. An interview on 04/10/24 at 11:05 a.m. with Employee #1 regarding the pre-treatment lab draw on Patient #6. Employee #1 stated they had drawn the waste blood because of accidentally instilling saline into the line prior to drawing the labs. Employee #1 then confirmed that the waste blood was returned to the patient, and that they now know it should never be returned, as it would increase the risk of infection. Employee #1 confirmed gloves were to be changed and hands sanitized anytime you leave a patient station and return; and that they had left the station to retrieve a syringe and returned without changing their gloves.”

“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: 38282 Based on observation, documentation review, and staff interview, the facility failed to ensure that policies and procedures were followed for obtaining pre-treatment labs on one (1) of one (1) patient (Patient #6) observed getting pre-treatment labs. This failure has the potential to affect all patients receiving bloodwork at the facility. Cross Reference: 494.140 Personnel Qualifications. Findings are as follows: A review of the policy, titled “Drawing Blood Work Pre-Treatment from an AVI/AVG or Catheter;” dated 05/02/22 stated, in part, “All bloodwork will be obtained following the same processes to ensure consistency and accuracy of the results.” The procedure for drawing the bloodwork from a CVC [central venous catheter] was reviewed, but did not include flushing the line prior to the draw or re-instilling the blood waste. An observation was conducted on 04/08/24 starting at 12:15 p.m. of Patient #6 at Station #1. Employee #1 was accessing the venous catheter for a pre-treatment lab draw prior to the initiation of dialysis. Employee #1 sanitized their hands, donned gloves, placed a barrier under the CVC, and flushed the port with ten milliliters (10 ml) of saline. Employee #1 stated: “Oh! I need to draw labs.” Then Employee #1, without removing the gloves, left station #1 and went to the nurses station, located diagonal to station #1, and was handed a 10 cc [cubic centimeter] syringe per request. Employee #1 returned to station #1, and without removing her gloves and sanitizing her hands, pulled 10 ml of “waste” blood into the syringe. Employee #1 laid the uncapped syringe of blood on the barrier, placed the vacutainer on the port and obtained the sample for testing, and picked up the syringe of blood and reinstalled it into the catheter. Dialysis was then initiated. An interview on 04/09/24 at 9:05 a.m. with Employee #2, confirmed that policy was not followed when Employee #1 drew labs from Patient #6’s CVC. Employee #2 stated, “The procedure does not include flushing the line prior to the draw, and it should not be done, as it could affect the results. The patient labs are scheduled monthly, and the labs should have been obtained on the next visit in order to ensure a more accurate result.” Employee #2 also confirmed that there was no policy about re-instilling waste blood, and that it would place the patient at risk for infection. Employee #2 stated an adverse event report was going to be placed, and that staff required retraining.”