Fresenius Medical Care Acworth

“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: 03383 Based on observation, staff interview, and a review of Policies and Procedures (P&P), it was determined that the facility failed to ensure that six of 20 patients (P) (P#12, P#13, P#14, P#19, P#20, P#24) observed, who held pressure to their access sites for hemostasis (stopping of the flow of blood after hemodialysis), performed hand hygiene (wash hands with soap and water or use an alcohol based hand sanitizer) after glove removal and prior to leaving the facility. This deficient practice had the potential for cross contamination and increased risk of infection and could affect 86 in-center hemodialysis patients who were dialyzing at this facility. Findings include: During observation in the Patient Treatment Room on 12/2/24 between 8:30 a.m. and 9:30 a.m., the following was observed: - P#19, P#24, and P#25 who were seated at Station (S) 2, S18, and S20 respectively, held pressure to their dialysis access sites for hemostasis and left the facility without performing hand hygiene. - P #19, P#24, and P#25 were not reminded by staff to wash their hands nor was hand sanitizer offered after glove removal. During observation in the Patient Treatment Room on 12/2/24 between 10:38 a.m. and 11:08 a.m., the following was observed: - P#12, P#13, and P#14 who were seated at S5, S5, and Isolation Room respectively, held pressure to their dialysis access sites for hemostasis and left the facility without performing hand hygiene. - P #12, P#13, and P#14 were not reminded by staff to wash their hands nor was hand sanitizer offered after glove removal. A review of Policy: 47664-001 titled, “Infection Control for Dialysis Facilities” with last revision date of 7/20/21 showed: Hand hygiene is to be performed upon entering the facility, prior to gloving, after removal of gloves... before leaving the patient care area. During an interview with the Director of Operations on 12/3/24 at 10:20 a.m., the above findings were discussed.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 03383 Based on observation and staff interview, it was determined that the facility failed to provide a safe environment for 86 patients and all staff as evidenced by holes in the wall. This environmental concern was observed in one of one treatment area. Findings include: During tour of the facility on 12/3/24 at 10:42 a.m. with the Director of Operations (DO), a 12-to-15-inch in length and 2-3 inches in width section of drywall/plaster flaking off was observed on the wall next to Station 21 in the treatment area. The DO acknowledged concern with this area on 12/3/24 at approximately 10:45 a.m. and stated that it will have to be repaired.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 03383 Based on observation and staff interviews, it was determined that the facility failed to ensure that four of 20 patients (P) (P#15, P#16, P#17 and P#18) on 12/2/24 and five of 20 patients (P#19, P#20, P#21, P#22 and P#23) on 12/3/24 observed, had their vascular access sites uncovered and visible to the Direct Patient Care (DPC) staff throughout their hemodialysis treatment, to ensure patient safety. This deficient practice could provide an opportunity for accidental needle dislodgement or a line disconnection to go undetected and could result in exsanguination (severe loss of blood). The facility census was 86. Findings include: An observation in the patient treatment area on 12/2/24 between 10:38 a.m. and 11:08 a.m. revealed the following: - P#15 who was seated at Station (S) 7 had access completely covered by a blanket. - P#16 who was seated at S10 had access completely covered by a blanket. - P#17 who was seated at S16 had access completely covered by a blanket. - P#18 who was seated at S20 had access completely covered by a blanket. The patients’ dialysis access sites were not visible during their treatment. During an interview with the Pool Registered Nurse (RN) at 11:15 a.m. on 12/2/24, the RN stated that patients complained about the cold temperature in the treatment area and refused to keep access uncovered. An observation in the patient treatment area on 12/3/24 between 8:30 a.m. and 9:30 a.m. revealed the following: - P#19 who was seated at S2 had access completely covered by a blanket. - P#20 who was seated at S3 had access completely covered by a blanket. - P#21 who was seated at S4 had access completely covered by a blanket. - P#22 who was seated at S6 had access completely covered by a blanket. - P#23 who was seated at S10 had access completely covered by a blanket. The Director of Operations (DO) was notified of the above findings on 12/2/24 at 11:58 a.m. The DO removed the blanket from the patients’ accesses and instructed the patients to keep their access uncovered.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 03383 Based on review of medical records, staff and patient interviews, and review of policy and procedures, it was determined that the facility failed to ensure that the plan of care was reviewed and signed by the patient or the patient’s designee in 10 of 10 (P#1 P#2, P#3, P#4, P#5, P#6, P#7, P#8, P#9, and P#10) patient care plans reviewed. This failure could negatively affect the health and safety of 86 patients who were dialyzing at this facility. Findings include: A eview of the patient care plans revealed the following: - P#1’s care plan dated 11/22/24 did not include the patient’s signature. - P#2’s care plan dated 10/10/24 did not include the patient’s signature. - P#3’s care plan dated 10/6/24 did not include the patient’s signature. - P#4’s care plan dated 11/14/24 did not include the patient’s signature. - P#5’s care plan dated 10/10/24 did not include the patient’s signature. - P#6’s care plan dated 1/26/24 did not include the patient’s signature. - P#7’s care plan dated 9/24/24 did not include the patient’s signature. - P#8’s care plan dated 3/27/24 did not include the patient’s signature. - P#9’s care plan dated 3/27/24 did not include the patient’s signature.. - P#10’s care plan dated 11/21/24 did not include the patient’s signature. During an interview with the Director of Operations on 12/4/24 at 8:30 a.m., she confirmed that she reviewed all 10 sampled patients’ care plans and none of them were signed by the patients. During an interview with P#1, P#4, P#11, and P#12 on 12/4/24 between 9:50 a.m. - 12:20 p.m., it was revealed that plan of care meetings were held at chairside during dialysis treatment. A review of Policy: 45283 titled “Comprehensive Interdisciplinary Assessment and Plan of Care” dated 7/23/23 showed “The plan should be signed at the time of the IDP meeting for those attending in person. If unable to sign at the time of the meeting or if attending remotely, the care plan must be signed by the IDP member within 30 days of the interdisciplinary team meeting.””

“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: 03383 Based on a review of medical records, staff interviews, and review of policy and procedures (P&P), it was determined that the medical director failed to ensure that all Direct Patient Care Staff adhered to facility policies pertaining to hypertension [elevated blood pressure (BP)] to ensure that two of two sampled patients (P#2, P#8) who experienced elevated blood pressures received medical care/interventions appropriate to the patient’s dialysis needs. High BP can lead to many complications, including heart disease and stroke. The facility census was 86. Findings include: P#2: P#2 had the following orders: 7/27/23: Clonidine HCL 0.1 mg (milligram) PO (by mouth) PRN (as needed). If systolic (top number) BP >/= (greater or equal to) 200 may repeat Clonidine 0.1 mg PO every 30 minutes prn (max 0.3 mg per treatment). Notify MD if post treatment systolic BP more than 200. A review of P#2 treatment flowsheets dated 10/19/24 - 11/27/24 revealed the following: On 10/19/24: - At 11:12 a.m., P#2’s BP was 210/128 mm Hg (millimeters of mercury) with a heart rate of 101 at the start of treatment. - At 11:30 a.m., BP was 196/119 mm Hg. - At 12:01 p.m., BP was 177/112 mm Hg. There was a lack of documented evidence to show Patient Care Technician (PCT) repositioned cuff and rechecked BP or notified the nurse about systolic BP greater than 180 and diastolic BP greater than 100 per policy. On 10/31/24: - At 11:28 a.m., P#2’s BP was 198/109 mm Hg. - At 11:32 a.m., P#2’s BP was 184/100 mm Hg - At 12:35 p.m., P#2’s BP was 172/104 mm Hg. - At 1:02 p.m., P#2’s BP was 161/123 mm Hg. The patient complained of cramping. There was an entry at 1:02 p.m. that showed PCT NN repositioned cuff. - At 1:31 p.m., P#2’s BP was 167/82 and the nurse was notified. There was a lack of documented evidence that showed PCT repositioned cuff and rechecked BP or notified the nurse about systolic BP greater than 180 and diastolic BP greater than 100 per policy until 1:31 p.m.. On 11/21/24: - At 10:55 a.m., P#2’s BP was 194/102 mm Hg. - At 11:30 a.m., P#2’s BP was 178/109 mm Hg. - At 12:02 p.m., P#2’s BP was 179/101 mm Hg. - At 2:10 p.m., P#2’s BP was 173/108 mm Hg. There was a lack of documented evidence that PCT repositioned cuff and rechecked BP or notified the nurse about systolic BP greater than 180 and diastolic BP greater than 100 per policy. On 11/23/24: - At 11:37 a.m., P#2’s BP was 192/118 mm Hg. - At 12:05 p.m., P#2’s BP was 179/108 mm Hg. - At 12:31 p.m., P#2’s BP was 180/110 mm Hg. There was a lack of documented evidence that PCT repositioned cuff and rechecked BP or notified the nurse about systolic BP greater than 180 and diastolic BP greater than 100 per policy. On 11/27/24: - At 11:18 a.m., P#2’s BP was 180/118 mm Hg at the start of treatment. - At 11:35 a.m., P#2’s BP was 171/108 mm Hg. - At 11:59 a.m., P#2’s BP was 180/111 mm Hg. There was a lack of documented evidence that PCT repositioned cuff and rechecked BP or notified the nurse about systolic BP greater than 180 and diastolic BP greater than 100 per policy. On 11/30/24: - At 11:14 a.m., P#2’s BP was 183/120 mm Hg at the start of treatment. - At 11:35 a.m., P#2’s BP was 187/118 mm Hg. - At 12:01 p.m., P#2’s BP was 162/104 mm Hg. - At 12:38 p.m., P#2’s BP was 165/102 mm Hg.. - At 1:05 p.m., P#2’s BP was 180/111 mm Hg. - At 1:31 p.m., P#2’s BP was 176/105 mm Hg. - At 2:03 p.m., P#2’s BP was 187/108 mm Hg.. Treatment was ended early per patient’s request. There was a lack of documented evidence that showed PCT repositioned cuff and rechecked BP or notified the nurse about systolic BP greater than 180 and diastolic BP greater than 100 per policy. During an interview with the Director of Operations (DO) on 12/3/24 at 6:45 a.m., the DO confirmed no actions were taken per policy and stated that staff would need retraining. P#8: On 11/20/24: - At 10:37 a.m., P#8’s BP was 184/78 mm Hg. - At 11:08 a.m., P#8’s BP was 187/118 mm Hg. - At 11:33 a.m., P#8’s BP was 193/100 mm Hg. - At 12:37 p.m., P#8’s BP was 153/69. There was a lack of documented evidence that PCT NN repositioned cuff and rechecked BP or notified the nurse about systolic BP greater than 180 per facility policy. On 11/22/24: - At 11:02 a.m., P#8’s BP was 195/84 mm Hg. - At 11:32 a.m., P#8’s BP was 133/115 mm Hg. - At 12:03 p.m., P#8’s BP was 166/138 mm Hg. There was a lack of documented evidence that PCT NN repositioned cuff and rechecked BP or notified the nurse about systolic BP greater than 180 per facility policy. Recommendation listed on page 10 of treatment record showed Registered Nurse (RN) FF entered the following at 11:41 a.m.: “4 of 6 prior treatments, patient required increased time for adequate fluid removal. Update HD (hemodialysis) order to increase treatment by 15 minutes.” Current dialysis time is 3 hours and should have been increased to 3.15 hours based on the recommendation. This order was not initiated on treatment records dated 11/24/24, 11/27/24, 11/30/24, and 12/2/24. The patient dialyzed for 3 hours only. On 11/24/24: - At 12:30 p.m., P#8’s BP was 193/81 mm Hg. - At 1:34 p.m., P#8’s BP was 199/85 mm Hg at the end of dialysis. There was a lack of documented evidence that PCT repositioned cuff and rechecked BP or notified the nurse about systolic BP greater than 180 and diastolic BP greater than 100 per policy. During an interview on 12/4/24 at 9:23 a.m., the DO confirmed the above findings. A review of Policy titled, “Hypertension” dated 9/7/21 showed the following: Staff will recognize, report, and immediately address systolic blood pressures greater than 180 mm/Hg and/or diastolic blood pressures greater than 100 mm/Hg. Treating Hypertension Follow the steps below to address hypertension: Action: 1. Notify the nurse in charge if a patient has a systolic blood pressure greater than 180 mm/Hg and/or diastolic blood pressure greater than 100 mm/Hg. 2. The RN will assess the patient and determine if further nursing interventions are needed. 3. If hypertension is related to hypervolemia... Follow CMAB Fluid Management algorithm or notify physician for possible estimated dry weight adjustment outside of algorithm parameters. 4. If hypertension is not related to hypervolemia, notify the physician for additional orders/interventions. 5. Document in patient’s treatment record.”